Analyzing surgical trends by a surgical system

ABSTRACT

Various surgical systems configured to analyze surgical procedure trends are disclosed. The surgical systems can further be configured to provide recommendations and/or adjust control algorithms executed by the surgical systems according to the identified trends. The identified trends can be utilized to determine a baseline or recommended action to be performed at a decision point in a surgical procedure. The surgical systems can be configured to provide preoperative, intraoperative, or postoperative feedback to users based on their decisions at the decision points relative to the determined baseline or recommended actions.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority under 35 U.S.C. § 120 to U.S. patentapplication Ser. No. 16/729,772, titled ANALYZING SURGICAL TRENDS BY ASURGICAL SYSTEM, filed Dec. 30, 2019, the disclosure of which is hereinincorporated by reference in its entirety.

BACKGROUND

Surgical systems often incorporate an imaging system, which can allowthe clinician(s) to view the surgical site and/or one or more portionsthereof on one or more displays such as a monitor, for example. Thedisplay(s) can be local and/or remote to a surgical theater. An imagingsystem can include a scope with a camera that views the surgical siteand transmits the view to a display that is viewable by a clinician.Scopes include, but are not limited to, arthroscopes, angioscopes,bronchoscopes, choledochoscopes, colonoscopes, cytoscopes,duodenoscopes, enteroscopes, esophagogastro-duodenoscopes(gastroscopes), endoscopes, laryngoscopes, nasopharyngo-neproscopes,sigmoidoscopes, thoracoscopes, ureteroscopes, and exoscopes. Imagingsystems can be limited by the information that they are able torecognize and/or convey to the clinician(s). For example, certainconcealed structures, physical contours, and/or dimensions within athree-dimensional space may be unrecognizable intraoperatively bycertain imaging systems. Additionally, certain imaging systems may beincapable of communicating and/or conveying certain information to theclinician(s) intraoperatively.

SUMMARY

In one general aspect, a surgical control system communicablyconnectable to a back-end computer system is disclosed. The surgicalcontrol system includes an imaging system and a control circuit coupledto the imaging system. The imaging system includes an emitter configuredto emit electromagnetic radiation (EMR) and an image sensor configuredto receive the EMR reflected from a surgical site. At least a portion ofthe EMR is emitted as structured EMR. The control circuit is configuredto generate an image of the surgical site via the reflected EMR receivedby the image sensor, determine a surgical action being performed basedon the image, receive a baseline surgical action associated with thesurgical action from the back-end computer system, and provide a userrecommendation according to a comparison between the surgical action andthe baseline surgical action.

In another general aspect, a computer system communicably connectable toa plurality of surgical hubs is disclosed. The plurality of surgicalhubs each communicably connectable to an imaging system. The computersystem includes a control circuit configured to receive, from theplurality of surgical hubs, a plurality of images of a plurality ofsurgical sites as captured by each imaging system during a plurality ofsurgical procedures, determine a plurality of surgical outcomes, each ofthe plurality of surgical outcomes associated with one of the pluralityof surgical procedures and based upon one of the plurality of images,determine a baseline surgical action according to the plurality ofimages and the plurality of surgical outcomes, and transmit the baselinesurgical action to the plurality of surgical hubs.

In yet another general aspect, a method of controlling a surgical systemcommunicably connectable to a back-end computer system is disclosed. Thecontrol system includes an imaging system. The imaging system includesan emitter configured to emit electromagnetic radiation (EMR). At leasta portion of the EMR is emitted as structured EMR and an image sensorconfigured to receive the EMR reflected from a surgical site. The methodincludes generating an image of the surgical site via the reflected EMRreceived by the image sensor, determining a surgical action beingperformed based on the image, receiving a baseline surgical actionassociated with the surgical action from the back-end computer system,and providing a user recommendation according to a comparison betweenthe surgical action and the baseline surgical action.

FIGURES

The novel features of the various aspects are set forth withparticularity in the appended claims. The described aspects, however,both as to organization and methods of operation, may be best understoodby reference to the following description, taken in conjunction with theaccompanying drawings in which:

FIG. 1 is a schematic of a surgical visualization system including animaging device and a surgical device, the surgical visualization systemconfigured to identify a critical structure below a tissue surface,according to at least one aspect of the present disclosure.

FIG. 2 is a schematic of a control system for a surgical visualizationsystem, according to at least one aspect of the present disclosure.

FIG. 2A illustrates a control circuit configured to control aspects of asurgical visualization system, according to at least one aspect of thepresent disclosure.

FIG. 2B illustrates a combinational logic circuit configured to controlaspects of a surgical visualization system, according to at least oneaspect of the present disclosure.

FIG. 2C illustrates a sequential logic circuit configured to controlaspects of a surgical visualization system, according to at least oneaspect of the present disclosure.

FIG. 3 is a schematic depicting triangularization between the surgicaldevice, the imaging device, and the critical structure of FIG. 1 todetermine a depth d_(A) of the critical structure below the tissuesurface, according to at least one aspect of the present disclosure.

FIG. 4 is a schematic of a surgical visualization system configured toidentify a critical structure below a tissue surface, wherein thesurgical visualization system includes a pulsed light source fordetermining a depth d_(A) of the critical structure below the tissuesurface, according to at least one aspect of the present disclosure.

FIG. 5 is a schematic of a surgical visualization system including animaging device and a surgical device, the surgical visualization systemconfigured to identify a critical structure below a tissue surface,according to at least one aspect of the present disclosure.

FIG. 6 is a schematic of a surgical visualization system including athree-dimensional camera, wherein the surgical visualization system isconfigured to identify a critical structure that is embedded withintissue, according to at least one aspect of the present disclosure.

FIGS. 7A and 7B are views of the critical structure taken by thethree-dimensional camera of FIG. 6, in which FIG. 7A is a view from aleft-side lens of the three-dimensional camera and FIG. 7B is a viewfrom a right-side lens of the three-dimensional camera, according to atleast one aspect of the present disclosure.

FIG. 8 is a schematic of the surgical visualization system of FIG. 6, inwhich a camera-to-critical structure distance d_(w) from thethree-dimensional camera to the critical structure can be determined,according to at least one aspect of the present disclosure.

FIG. 9 is a schematic of a surgical visualization system utilizing twocameras to determine the position of an embedded critical structure,according to at least one aspect of the present disclosure.

FIG. 10A is a schematic of a surgical visualization system utilizing acamera that is moved axially between a plurality of known positions todetermine a position of an embedded critical structure, according to atleast one aspect of the present disclosure.

FIG. 10B is a schematic of the surgical visualization system of FIG.10A, in which the camera is moved axially and rotationally between aplurality of known positions to determine a position of the embeddedcritical structure, according to at least one aspect of the presentdisclosure.

FIG. 11 is a schematic of a control system for a surgical visualizationsystem, according to at least one aspect of the present disclosure.

FIG. 12 is a schematic of a structured light source for a surgicalvisualization system, according to at least one aspect of the presentdisclosure.

FIG. 13A is a graph of absorption coefficient verse wavelength forvarious biological materials, according to at least one aspect of thepresent disclosure.

FIG. 13B is a schematic of the visualization of anatomical structuresvia a spectral surgical visualization system, according to at least oneaspect of the present disclosure.

FIGS. 13C-13E depict illustrative hyperspectral identifying signaturesto differentiate anatomy from obscurants, wherein FIG. 13C is agraphical representation of a ureter signature versus obscurants, FIG.13D is a graphical representation of an artery signature versusobscurants, and FIG. 13E is a graphical representation of a nervesignature versus obscurants, according to at least one aspect of thepresent disclosure.

FIG. 14 is a schematic of a near infrared (NIR) time-of-flightmeasurement system configured to sense distance to a critical anatomicalstructure, the time-of-flight measurement system including a transmitter(emitter) and a receiver (sensor) positioned on a common device,according to at least one aspect of the present disclosure.

FIG. 15 is a schematic of an emitted wave, a received wave, and a delaybetween the emitted wave and the received wave of the NIR time-of-flightmeasurement system of FIG. 17A, according to at least one aspect of thepresent disclosure.

FIG. 16 illustrates a NIR time-of-flight measurement system configuredto sense a distance to different structures, the time-of-flightmeasurement system including a transmitter (emitter) and a receiver(sensor) on separate devices, according to at least one aspect of thepresent disclosure.

FIG. 17 is a block diagram of a computer-implemented interactivesurgical system, according to at least one aspect of the presentdisclosure.

FIG. 18 is a surgical system being used to perform a surgical procedurein an operating room, according to at least one aspect of the presentdisclosure.

FIG. 19 illustrates a computer-implemented interactive surgical system,according to at least one aspect of the present disclosure.

FIG. 20 illustrates a diagram of a situationally aware surgical system,according to at least one aspect of the present disclosure.

FIG. 21 illustrates a timeline depicting situational awareness of a hub,according to at least one aspect of the present disclosure.

FIG. 22 is a diagram of a surgical system, in accordance with at leastone aspect of the present disclosure.

FIG. 23 is a logic flow diagram of a process for providing dynamicsurgical recommendations to users, in accordance with at least oneaspect of the present disclosure.

FIG. 24 is a surgical visualization displaying a recommended surgicalinstrument position, in accordance with at least one aspect of thepresent disclosure.

DESCRIPTION

Applicant of the present application owns the following U.S. PatentApplications, filed on Dec. 30, 2019, each of which is hereinincorporated by reference in its entirety:

U.S. patent application Ser. No. 16/729,807, titled METHOD OF USINGIMAGING DEVICES IN SURGERY;

U.S. patent application Ser. No. 16/729,803, titled ADAPTIVEVISUALIZATION BY A SURGICAL SYSTEM;

U.S. patent application Ser. No. 16/729,790, titled SURGICAL SYSTEMCONTROL BASED ON MULTIPLE SENSED PARAMETERS;

U.S. patent application Ser. No. 16/729,796, titled ADAPTIVE SURGICALSYSTEM CONTROL ACCORDING TO SURGICAL SMOKE PARTICLE CHARACTERISTICS;

U.S. patent application Ser. No. 16/729,737, titled ADAPTIVE SURGICALSYSTEM CONTROL ACCORDING TO SURGICAL SMOKE CLOUD CHARACTERISTICS;

U.S. patent application Ser. No. 16/729,740, titled SURGICAL SYSTEMSCORRELATING VISUALIZATION DATA AND POWERED SURGICAL INSTRUMENT DATA;

U.S. patent application Ser. No. 16/729,751, titled SURGICAL SYSTEMS FORGENERATING THREE DIMENSIONAL CONSTRUCTS OF ANATOMICAL ORGANS ANDCOUPLING IDENTIFIED;

U.S. patent application Ser. No. 16/729,735, titled SURGICAL SYSTEM FOROVERLAYING SURGICAL INSTRUMENT DATA ONTO A VIRTUAL THREE DIMENSIONALCONSTRUCT OF AN ORGAN;

U.S. patent application Ser. No. 16/729,729, titled SURGICAL SYSTEMS FORPROPOSING AND CORROBORATING ORGAN PORTION REMOVALS;

U.S. patent application Ser. No. 16/729,778, titled SYSTEM AND METHODFOR DETERMINING, ADJUSTING, AND MANAGING RESECTION MARGIN ABOUT ASUBJECT TISSUE;

U.S. patent application Ser. No. 16/729,744, titled VISUALIZATIONSYSTEMS USING STRUCTURED LIGHT; and

U.S. patent application Ser. No. 16/729,747, titled DYNAMIC SURGICALVISUALIZATION SYSTEMS.

Applicant of the present application owns the following U.S. PatentApplications, filed on Mar. 15, 2019, each of which is hereinincorporated by reference in its entirety:

U.S. patent application Ser. No. 16/354,417, titled INPUT CONTROLS FORROBOTIC SURGERY, now U.S. Patent Application Publication No.2020/0289219;

U.S. patent application Ser. No. 16/354,420, titled DUAL MODE CONTROLSFOR ROBOTIC SURGERY, now U.S. Patent Application Publication No.2020/0289228;

U.S. patent application Ser. No. 16/354,422, titled MOTION CAPTURECONTROLS FOR ROBOTIC SURGERY, now U.S. Patent Application PublicationNo. 2020/0289216;

U.S. patent application Ser. No. 16/354,440, titled ROBOTIC SURGICALSYSTEMS WITH MECHANISMS FOR SCALING SURGICAL TOOL MOTION ACCORDING TOTISSUE PROXIMITY, now U.S. Patent Application Publication No.2020/0289220;

U.S. patent application Ser. No. 16/354,444, titled ROBOTIC SURGICALSYSTEMS WITH MECHANISMS FOR SCALING CAMERA MAGNIFICATION ACCORDING TOPROXIMITY OF SURGICAL TOOL TO TISSUE, now U.S. Patent ApplicationPublication No. 2020/0289205;

U.S. patent application Ser. No. 16/354,454, titled ROBOTIC SURGICALSYSTEMS WITH SELECTIVELY LOCKABLE END EFFECTORS, now U.S. PatentApplication Publication No. 2020/0289221;

U.S. patent application Ser. No. 16/354,461, titled SELECTABLE VARIABLERESPONSE OF SHAFT MOTION OF SURGICAL ROBOTIC SYSTEMS, now U.S. PatentApplication Publication No. 2020/0289222;

U.S. patent application Ser. No. 16/354,470, titled SEGMENTED CONTROLINPUTS FOR SURGICAL ROBOTIC SYSTEMS, now U.S. Patent ApplicationPublication No. 2020/0289223;

U.S. patent application Ser. No. 16/354,474, titled ROBOTIC SURGICALCONTROLS HAVING FEEDBACK CAPABILITIES, now U.S. Patent ApplicationPublication No. 2020/0289229;

U.S. patent application Ser. No. 16/354,478, titled ROBOTIC SURGICALCONTROLS WITH FORCE FEEDBACK, now U.S. Patent Application PublicationNo. 2020/0289230; and

U.S. patent application Ser. No. 16/354,481, titled JAW COORDINATION OFROBOTIC SURGICAL CONTROLS, now U.S. Patent Application Publication No.2020/0289217.

Applicant of the present application also owns the following U.S. PatentApplications, filed on Sep. 11, 2018, each of which is hereinincorporated by reference in its entirety:

U.S. patent application Ser. No. 16/128,179, titled SURGICALVISUALIZATION PLATFORM, now U.S. Pat. No. 11,000,270;

U.S. patent application Ser. No. 16/128,180, titled CONTROLLING ANEMITTER ASSEMBLY PULSE SEQUENCE, now U.S. Patent Application PublicationNo. 2020/0015900;

U.S. patent application Ser. No. 16/128,198, titled SINGULAR EMR SOURCEEMITTER ASSEMBLY, now U.S. Patent Application Publication No.2020/0015668;

U.S. patent application Ser. No. 16/128,207, titled COMBINATION EMITTERAND CAMERA ASSEMBLY, now U.S. Patent Application Publication No.2020/0015925;

U.S. patent application Ser. No. 16/128,176, titled SURGICALVISUALIZATION WITH PROXIMITY TRACKING FEATURES, now U.S. PatentApplication Publication No. 2020/0015899;

U.S. patent application Ser. No. 16/128,187, titled SURGICALVISUALIZATION OF MULTIPLE TARGETS, now U.S. Patent ApplicationPublication No. 2020/0015903;

U.S. patent application Ser. No. 16/128,192, titled VISUALIZATION OFSURGICAL DEVICES, now U.S. Pat. No. 10,792,034;

U.S. patent application Ser. No. 16/128,163, titled OPERATIVECOMMUNICATION OF LIGHT, now U.S. Patent Application Publication No.2020/0015897;

U.S. patent application Ser. No. 16/128,197, titled ROBOTIC LIGHTPROJECTION TOOLS, now U.S. Patent Application Publication No.2020/0015924;

U.S. patent application Ser. No. 16/128,164, titled SURGICALVISUALIZATION FEEDBACK SYSTEM, now U.S. Patent Application PublicationNo. 2020/0015898;

U.S. patent application Ser. No. 16/128,193, titled SURGICALVISUALIZATION AND MONITORING, now U.S. Patent Application PublicationNo. 2020/0015906;

U.S. patent application Ser. No. 16/128,195, titled INTEGRATION OFIMAGING DATA, now U.S. Patent Application Publication No. 2020/0015907;

U.S. patent application Ser. No. 16/128,170, titled ROBOTICALLY-ASSISTEDSURGICAL SUTURING SYSTEMS, now U.S. Pat. No. 10,925,598;

U.S. patent application Ser. No. 16/128,183, titled SAFETY LOGIC FORSURGICAL SUTURING SYSTEMS, now U.S. Patent Application Publication No.2020/0015901;

U.S. patent application Ser. No. 16/128,172, titled ROBOTIC SYSTEM WITHSEPARATE PHOTOACOUSTIC RECEIVER, now U.S. Patent Application PublicationNo. 2020/0015914; and

U.S. patent application Ser. No. 16/128,185, titled FORCE SENSOR THROUGHSTRUCTURED LIGHT DEFLECTION, now U.S. Patent Application Publication No.2020/0015902.

Applicant of the present application also owns the following U.S. PatentApplications, filed on Mar. 29, 2018, each of which is hereinincorporated by reference in its entirety:

U.S. patent application Ser. No. 15/940,627, titled DRIVE ARRANGEMENTSFOR ROBOT-ASSISTED SURGICAL PLATFORMS, now U.S. Pat. No. 11,013,563;

U.S. patent application Ser. No. 15/940,676, titled AUTOMATIC TOOLADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS, now U.S. PatentApplication Publication No. 2019/0201142;

U.S. patent application Ser. No. 15/940,711, titled SENSING ARRANGEMENTSFOR ROBOT-ASSISTED SURGICAL PLATFORMS, now U.S. Patent ApplicationPublication No. 2019/0201120; and

U.S. patent application Ser. No. 15/940,722, titled CHARACTERIZATION OFTISSUE IRREGULARITIES THROUGH THE USE OF MONO-CHROMATIC LIGHTREFRACTIVITY, now U.S. Patent Application Publication No. 2019/0200905.

Applicant of the present application owns the following U.S. PatentApplications, filed on Dec. 4, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

U.S. patent application Ser. No. 16/209,395, titled METHOD OF HUBCOMMUNICATION, now U.S. Patent Application Publication No. 2019/0201136;

U.S. patent application Ser. No. 16/209,403, titled METHOD OF CLOUDBASED DATA ANALYTICS FOR USE WITH THE HUB, now U.S. Patent ApplicationPublication No. 2019/0206569;

U.S. patent application Ser. No. 16/209,407, titled METHOD OF ROBOTICHUB COMMUNICATION, DETECTION, AND CONTROL, now U.S. Patent ApplicationPublication No. 2019/0201137;

U.S. patent application Ser. No. 16/209,416, titled METHOD OF HUBCOMMUNICATION, PROCESSING, DISPLAY, AND CLOUD ANALYTICS, now U.S. PatentApplication Publication No. 2019/0206562;

U.S. patent application Ser. No. 16/209,423, titled METHOD OFCOMPRESSING TISSUE WITHIN A STAPLING DEVICE AND SIMULTANEOUSLYDISPLAYING THE LOCATION OF THE TISSUE WITHIN THE JAWS, now U.S. PatentApplication Publication No. 2019/0200981;

U.S. patent application Ser. No. 16/209,427, titled METHOD OF USINGREINFORCED FLEXIBLE CIRCUITS WITH MULTIPLE SENSORS TO OPTIMIZEPERFORMANCE OF RADIO FREQUENCY DEVICES, now U.S. Patent ApplicationPublication No. 2019/0208641;

U.S. patent application Ser. No. 16/209,433, titled METHOD OF SENSINGPARTICULATE FROM SMOKE EVACUATED FROM A PATIENT, ADJUSTING THE PUMPSPEED BASED ON THE SENSED INFORMATION, AND COMMUNICATING THE FUNCTIONALPARAMETERS OF THE SYSTEM TO THE HUB, now U.S. Patent ApplicationPublication No. 2019/0201594;

U.S. patent application Ser. No. 16/209,447, titled METHOD FOR SMOKEEVACUATION FOR SURGICAL HUB, now U.S. Patent Application Publication No.2019/0201045;

U.S. patent application Ser. No. 16/209,453, titled METHOD FORCONTROLLING SMART ENERGY DEVICES, now U.S. Patent ApplicationPublication No. 2019/0201046;

U.S. patent application Ser. No. 16/209,458, titled METHOD FOR SMARTENERGY DEVICE INFRASTRUCTURE, now U.S. Patent Application PublicationNo. 2019/0201047;

U.S. patent application Ser. No. 16/209,465, titled METHOD FOR ADAPTIVECONTROL SCHEMES FOR SURGICAL NETWORK CONTROL AND INTERACTION, now U.S.Patent Application Publication No. 2019/0206563;

U.S. patent application Ser. No. 16/209,478, titled METHOD FORSITUATIONAL AWARENESS FOR SURGICAL NETWORK OR SURGICAL NETWORK CONNECTEDDEVICE CAPABLE OF ADJUSTING FUNCTION BASED ON A SENSED SITUATION ORUSAGE, now U.S. Patent Application Publication No. 2019/0104919;

U.S. patent application Ser. No. 16/209,490, titled METHOD FOR FACILITYDATA COLLECTION AND INTERPRETATION, now U.S. Patent ApplicationPublication No. 2019/0206564; and

U.S. patent application Ser. No. 16/209,491, titled METHOD FOR CIRCULARSTAPLER CONTROL ALGORITHM ADJUSTMENT BASED ON SITUATIONAL AWARENESS, nowU.S. Patent Application Publication No. 2019/0200998.

Before explaining various aspects of a surgical visualization platformin detail, it should be noted that the illustrative examples are notlimited in application or use to the details of construction andarrangement of parts illustrated in the accompanying drawings anddescription. The illustrative examples may be implemented orincorporated in other aspects, variations, and modifications, and may bepracticed or carried out in various ways. Further, unless otherwiseindicated, the terms and expressions employed herein have been chosenfor the purpose of describing the illustrative examples for theconvenience of the reader and are not for the purpose of limitationthereof. Also, it will be appreciated that one or more of thefollowing-described aspects, expressions of aspects, and/or examples,can be combined with any one or more of the other following-describedaspects, expressions of aspects, and/or examples.

Surgical Visualization System

The present disclosure is directed to a surgical visualization platformthat leverages “digital surgery” to obtain additional information abouta patient's anatomy and/or a surgical procedure. The surgicalvisualization platform is further configured to convey data and/orinformation to one or more clinicians in a helpful manner. For example,various aspects of the present disclosure provide improved visualizationof the patient's anatomy and/or the surgical procedure.

“Digital surgery” can embrace robotic systems, advanced imaging,advanced instrumentation, artificial intelligence, machine learning,data analytics for performance tracking and benchmarking, connectivityboth inside and outside of the operating room (OR), and more. Althoughvarious surgical visualization platforms described herein can be used incombination with a robotic surgical system, surgical visualizationplatforms are not limited to use with a robotic surgical system. Incertain instances, advanced surgical visualization can occur withoutrobotics and/or with limited and/or optional robotic assistance.Similarly, digital surgery can occur without robotics and/or withlimited and/or optional robotic assistance.

In certain instances, a surgical system that incorporates a surgicalvisualization platform may enable smart dissection in order to identifyand avoid critical structures. Critical structures include anatomicalstructures such as a ureter, an artery such as a superior mesentericartery, a vein such as a portal vein, a nerve such as a phrenic nerve,and/or a tumor, among other anatomical structures. In other instances, acritical structure can be a foreign structure in the anatomical field,such as a surgical device, surgical fastener, clip, tack, bougie, band,and/or plate, for example. Critical structures can be determined on apatient-by-patient and/or a procedure-by-procedure basis. Examplecritical structures are further described herein.

Smart dissection technology may provide improved intraoperative guidancefor dissection and/or can enable smarter decisions with critical anatomydetection and avoidance technology, for example.

A surgical system incorporating a surgical visualization platform mayalso enable smart anastomosis technologies that provide more consistentanastomoses at optimal location(s) with improved workflow. Cancerlocalization technologies may also be improved with the various surgicalvisualization platforms and procedures described herein. For example,cancer localization technologies can identify and track a cancerlocation, orientation, and its margins. In certain instances, the cancerlocalizations technologies may compensate for movement of a tool, apatient, and/or the patient's anatomy during a surgical procedure inorder to provide guidance back to the point of interest for theclinician.

In certain aspects of the present disclosure, a surgical visualizationplatform may provide improved tissue characterization and/or lymph nodediagnostics and mapping. For example, tissue characterizationtechnologies may characterize tissue type and health without the needfor physical haptics, especially when dissecting and/or placing staplingdevices within the tissue. Certain tissue characterization technologiesdescribed herein may be utilized without ionizing radiation and/orcontrast agents. With respect to lymph node diagnostics and mapping, asurgical visualization platform may preoperatively locate, map, andideally diagnose the lymph system and/or lymph nodes involved incancerous diagnosis and staging, for example.

During a surgical procedure, the information available to the clinicianvia the “naked eye” and/or an imaging system may provide an incompleteview of the surgical site. For example, certain structures, such asstructures embedded or buried within an organ, can be at least partiallyconcealed or hidden from view. Additionally, certain dimensions and/orrelative distances can be difficult to ascertain with existing sensorsystems and/or difficult for the “naked eye” to perceive. Moreover,certain structures can move preoperatively (e.g. before a surgicalprocedure but after a preoperative scan) and/or intraoperatively. Insuch instances, the clinician can be unable to accurately determine thelocation of a critical structure intraoperatively.

When the position of a critical structure is uncertain and/or when theproximity between the critical structure and a surgical tool is unknown,a clinician's decision-making process can be inhibited. For example, aclinician may avoid certain areas in order to avoid inadvertentdissection of a critical structure; however, the avoided area may beunnecessarily large and/or at least partially misplaced. Due touncertainty and/or overly/excessive exercises in caution, the clinicianmay not access certain desired regions. For example, excess caution maycause a clinician to leave a portion of a tumor and/or other undesirabletissue in an effort to avoid a critical structure even if the criticalstructure is not in the particular area and/or would not be negativelyimpacted by the clinician working in that particular area. In certaininstances, surgical results can be improved with increased knowledgeand/or certainty, which can allow a surgeon to be more accurate and, incertain instances, less conservative/more aggressive with respect toparticular anatomical areas.

In various aspects, the present disclosure provides a surgicalvisualization system for intraoperative identification and avoidance ofcritical structures. In one aspect, the present disclosure provides asurgical visualization system that enables enhanced intraoperativedecision making and improved surgical outcomes. In various aspects, thedisclosed surgical visualization system provides advanced visualizationcapabilities beyond what a clinician sees with the “naked eye” and/orbeyond what an imaging system can recognize and/or convey to theclinician. The various surgical visualization systems can augment andenhance what a clinician is able to know prior to tissue treatment (e.g.dissection) and, thus, may improve outcomes in various instances.

For example, a visualization system can include a first light emitterconfigured to emit a plurality of spectral waves, a second light emitterconfigured to emit a light pattern, and one or more receivers, orsensors, configured to detect visible light, molecular responses to thespectral waves (spectral imaging), and/or the light pattern. It shouldbe noted that throughout the following disclosure, any reference to“light,” unless specifically in reference to visible light, can includeelectromagnetic radiation (EMR) or photons in the visible and/ornon-visible portions of the EMR wavelength spectrum. The surgicalvisualization system can also include an imaging system and a controlcircuit in signal communication with the receiver(s) and the imagingsystem. Based on output from the receiver(s), the control circuit candetermine a geometric surface map, i.e. three-dimensional surfacetopography, of the visible surfaces at the surgical site and one or moredistances with respect to the surgical site. In certain instances, thecontrol circuit can determine one more distances to an at leastpartially concealed structure. Moreover, the imaging system can conveythe geometric surface map and the one or more distances to a clinician.In such instances, an augmented view of the surgical site provided tothe clinician can provide a representation of the concealed structurewithin the relevant context of the surgical site. For example, theimaging system can virtually augment the concealed structure on thegeometric surface map of the concealing and/or obstructing tissuesimilar to a line drawn on the ground to indicate a utility line belowthe surface. Additionally or alternatively, the imaging system canconvey the proximity of one or more surgical tools to the visible andobstructing tissue and/or to the at least partially concealed structureand/or the depth of the concealed structure below the visible surface ofthe obstructing tissue. For example, the visualization system candetermine a distance with respect to the augmented line on the surfaceof the visible tissue and convey the distance to the imaging system.

In various aspects of the present disclosure, a surgical visualizationsystem is disclosed for intraoperative identification and avoidance ofcritical structures. Such a surgical visualization system can providevaluable information to a clinician during a surgical procedure. As aresult, the clinician can confidently maintain momentum throughout thesurgical procedure knowing that the surgical visualization system istracking a critical structure such as a ureter, specific nerves, and/orcritical blood vessels, for example, which may be approached duringdissection, for example. In one aspect, the surgical visualizationsystem can provide an indication to the clinician in sufficient time forthe clinician to pause and/or slow down the surgical procedure andevaluate the proximity to the critical structure to prevent inadvertentdamage thereto. The surgical visualization system can provide an ideal,optimized, and/or customizable amount of information to the clinician toallow the clinician to move confidently and/or quickly through tissuewhile avoiding inadvertent damage to healthy tissue and/or criticalstructure(s) and, thus, to minimize the risk of harm resulting from thesurgical procedure.

FIG. 1 is a schematic of a surgical visualization system 100 accordingto at least one aspect of the present disclosure. The surgicalvisualization system 100 can create a visual representation of acritical structure 101 within an anatomical field. The surgicalvisualization system 100 can be used for clinical analysis and/ormedical intervention, for example. In certain instances, the surgicalvisualization system 100 can be used intraoperatively to providereal-time, or near real-time, information to the clinician regardingproximity data, dimensions, and/or distances during a surgicalprocedure. The surgical visualization system 100 is configured forintraoperative identification of critical structure(s) and/or tofacilitate the avoidance of the critical structure(s) 101 by a surgicaldevice. For example, by identifying the critical structure 101, aclinician can avoid maneuvering a surgical device around the criticalstructure 101 and/or a region in a predefined proximity of the criticalstructure 101 during a surgical procedure. The clinician can avoiddissection of and/or near a vein, artery, nerve, and/or vessel, forexample, identified as the critical structure 101, for example. Invarious instances, the critical structure 101 can be determined on apatient-by-patient and/or a procedure-by-procedure basis.

The surgical visualization system 100 incorporates tissue identificationand geometric surface mapping in combination with a distance sensorsystem 104. In combination, these features of the surgical visualizationsystem 100 can determine a position of a critical structure 101 withinthe anatomical field and/or the proximity of a surgical device 102 tothe surface 105 of the visible tissue and/or to the critical structure101. Moreover, the surgical visualization system 100 includes an imagingsystem that includes an imaging device 120, such as a camera, forexample, configured to provide real-time views of the surgical site. Invarious instances, the imaging device 120 is a spectral camera (e.g. ahyperspectral camera, multispectral camera, or selective spectralcamera), which is configured to detect reflected spectral waveforms andgenerate a spectral cube of images based on the molecular response tothe different wavelengths. Views from the imaging device 120 can beprovided to a clinician and, in various aspects of the presentdisclosure, can be augmented with additional information based on thetissue identification, landscape mapping, and the distance sensor system104. In such instances, the surgical visualization system 100 includes aplurality of subsystems—an imaging subsystem, a surface mappingsubsystem, a tissue identification subsystem, and/or a distancedetermining subsystem. These subsystems can cooperate tointra-operatively provide advanced data synthesis and integratedinformation to the clinician(s).

The imaging device can include a camera or imaging sensor that isconfigured to detect visible light, spectral light waves (visible orinvisible), and a structured light pattern (visible or invisible), forexample. In various aspects of the present disclosure, the imagingsystem can include an imaging device such as an endoscope, for example.Additionally or alternatively, the imaging system can include an imagingdevice such as an arthroscope, angioscope, bronchoscope,choledochoscope, colonoscope, cytoscope, duodenoscope, enteroscope,esophagogastro-duodenoscope (gastroscope), laryngoscope,nasopharyngo-neproscope, sigmoidoscope, thoracoscope, ureteroscope, orexoscope, for example. In other instances, such as in open surgeryapplications, the imaging system may not include a scope.

In various aspects of the present disclosure, the tissue identificationsubsystem can be achieved with a spectral imaging system. The spectralimaging system can rely on hyperspectral imaging, multispectral imaging,or selective spectral imaging, for example. Hyperspectral imaging oftissue is further described in U.S. Pat. No. 9,274,047, titled SYSTEMAND METHOD FOR GROSS ANATOMIC PATHOLOGY USING HYPERSPECTRAL IMAGING,issued Mar. 1, 2016, which is incorporated by reference herein in itsentirety.

In various aspect of the present disclosure, the surface mappingsubsystem can be achieved with a light pattern system, as furtherdescribed herein. The use of a light pattern (or structured light) forsurface mapping is known. Known surface mapping techniques can beutilized in the surgical visualization systems described herein.

Structured light is the process of projecting a known pattern (often agrid or horizontal bars) on to a surface. U.S. Patent ApplicationPublication No. 2017/0055819, titled SET

COMPRISING A SURGICAL INSTRUMENT, published Mar. 2, 2017, and U.S.Patent Application Publication No. 2017/0251900, titled DEPICTIONSYSTEM, published Sep. 7, 2017, disclose a surgical system comprising alight source and a projector for projecting a light pattern. U.S. PatentApplication Publication No. 2017/0055819, titled SET COMPRISING ASURGICAL INSTRUMENT, published Mar. 2, 2017, and U.S. Patent ApplicationPublication No. 2017/0251900, titled DEPICTION SYSTEM, published Sep. 7,2017, are incorporated by reference herein in their respectiveentireties.

In various aspects of the present disclosure, the distance determiningsystem can be incorporated into the surface mapping system. For example,structured light can be utilized to generate a three-dimensional virtualmodel of the visible surface and determine various distances withrespect to the visible surface. Additionally or alternatively, thedistance determining system can rely on time-of-flight measurements todetermine one or more distances to the identified tissue (or otherstructures) at the surgical site.

FIG. 2 is a schematic diagram of a control system 133, which can beutilized with the surgical visualization system 100. The control system133 includes a control circuit 132 in signal communication with a memory134. The memory 134 stores instructions executable by the controlcircuit 132 to determine and/or recognize critical structures (e.g. thecritical structure 101 in FIG. 1), determine and/or compute one or moredistances and/or three-dimensional digital representations, and tocommunicate certain information to one or more clinicians. For example,the memory 134 stores surface mapping logic 136, imaging logic 138,tissue identification logic 140, or distance determining logic 141 orany combinations of the logic 136, 138, 140, and 141. The control system133 also includes an imaging system 142 having one or more cameras 144(like the imaging device 120 in FIG. 1), one or more displays 146, orone or more controls 148 or any combinations of these elements. Thecamera 144 can include one or more image sensors 135 to receive signalsfrom various light sources emitting light at various visible andinvisible spectra (e.g. visible light, spectral imagers,three-dimensional lens, among others). The display 146 can include oneor more screens or monitors for depicting real, virtual, and/orvirtually-augmented images and/or information to one or more clinicians.

In various aspects, the heart of the camera 144 is the image sensor 135.Generally, modern image sensors 135 are solid-state electronic devicescontaining up to millions of discrete photodetector sites called pixels.The image sensor 135 technology falls into one of two categories:Charge-Coupled Device (CCD) and Complementary Metal Oxide Semiconductor(CMOS) imagers and more recently, short-wave infrared (SWIR) is anemerging technology in imaging. Another type of image sensor 135 employsa hybrid CCD/CMOS architecture (sold under the name “sCMOS”) andconsists of CMOS readout integrated circuits (ROICs) that are bumpbonded to a CCD imaging substrate. CCD and CMOS image sensors 135 aresensitive to wavelengths from approximately 350-1050 nm, although therange is usually given from 400-1000 nm. CMOS sensors are, in general,more sensitive to IR wavelengths than CCD sensors. Solid state imagesensors 135 are based on the photoelectric effect and, as a result,cannot distinguish between colors. Accordingly, there are two types ofcolor CCD cameras: single chip and three-chip. Single chip color CCDcameras offer a common, low-cost imaging solution and use a mosaic (e.g.Bayer) optical filter to separate incoming light into a series of colorsand employ an interpolation algorithm to resolve full color images. Eachcolor is, then, directed to a different set of pixels. Three-chip colorCCD cameras provide higher resolution by employing a prism to directeach section of the incident spectrum to a different chip. More accuratecolor reproduction is possible, as each point in space of the object hasseparate RGB intensity values, rather than using an algorithm todetermine the color. Three-chip cameras offer extremely highresolutions.

The control system 133 also includes a spectral light source 150 and astructured light source 152. In certain instances, a single source canbe pulsed to emit wavelengths of light in the spectral light source 150range and wavelengths of light in the structured light source 152 range.Alternatively, a single light source can be pulsed to provide light inthe invisible spectrum (e.g. infrared spectral light) and wavelengths oflight on the visible spectrum. The spectral light source 150 can be ahyperspectral light source, a multispectral light source, and/or aselective spectral light source, for example. In various instances, thetissue identification logic 140 can identify critical structure(s) viadata from the spectral light source 150 received by the image sensor 135portion of the camera 144. The surface mapping logic 136 can determinethe surface contours of the visible tissue based on reflected structuredlight. With time-of-flight measurements, the distance determining logic141 can determine one or more distance(s) to the visible tissue and/orthe critical structure 101. One or more outputs from the surface mappinglogic 136, the tissue identification logic 140, and the distancedetermining logic 141, can be provided to the imaging logic 138, andcombined, blended, and/or overlaid to be conveyed to a clinician via thedisplay 146 of the imaging system 142.

The description now turns briefly to FIGS. 2A-2C to describe variousaspects of the control circuit 132 for controlling various aspects ofthe surgical visualization system 100. Turning to FIG. 2A, there isillustrated a control circuit 400 configured to control aspects of thesurgical visualization system 100, according to at least one aspect ofthis disclosure. The control circuit 400 can be configured to implementvarious processes described herein. The control circuit 400 may comprisea microcontroller comprising one or more processors 402 (e.g.,microprocessor, microcontroller) coupled to at least one memory circuit404. The memory circuit 404 stores machine-executable instructions that,when executed by the processor 402, cause the processor 402 to executemachine instructions to implement various processes described herein.The processor 402 may be any one of a number of single-core or multicoreprocessors known in the art. The memory circuit 404 may comprisevolatile and non-volatile storage media. The processor 402 may includean instruction processing unit 406 and an arithmetic unit 408. Theinstruction processing unit may be configured to receive instructionsfrom the memory circuit 404 of this disclosure.

FIG. 2B illustrates a combinational logic circuit 410 configured tocontrol aspects of the surgical visualization system 100, according toat least one aspect of this disclosure. The combinational logic circuit410 can be configured to implement various processes described herein.The combinational logic circuit 410 may comprise a finite state machinecomprising a combinational logic 412 configured to receive dataassociated with the surgical instrument or tool at an input 414, processthe data by the combinational logic 412, and provide an output 416.

FIG. 2C illustrates a sequential logic circuit 420 configured to controlaspects of the surgical visualization system 100, according to at leastone aspect of this disclosure. The sequential logic circuit 420 or thecombinational logic 422 can be configured to implement various processesdescribed herein. The sequential logic circuit 420 may comprise a finitestate machine. The sequential logic circuit 420 may comprise acombinational logic 422, at least one memory circuit 424, and a clock429, for example. The at least one memory circuit 424 can store acurrent state of the finite state machine. In certain instances, thesequential logic circuit 420 may be synchronous or asynchronous. Thecombinational logic 422 is configured to receive data associated with asurgical device or system from an input 426, process the data by thecombinational logic 422, and provide an output 428. In other aspects,the circuit may comprise a combination of a processor (e.g., processor402 in FIG. 2A) and a finite state machine to implement variousprocesses herein. In other aspects, the finite state machine maycomprise a combination of a combinational logic circuit (e.g.,combinational logic circuit 410, FIG. 2B) and the sequential logiccircuit 420.

Referring again to the surgical visualization system 100 in FIG. 1, thecritical structure 101 can be an anatomical structure of interest. Forexample, the critical structure 101 can be a ureter, an artery such as asuperior mesenteric artery, a vein such as a portal vein, a nerve suchas a phrenic nerve, and/or a tumor, among other anatomical structures.In other instances, the critical structure 101 can be a foreignstructure in the anatomical field, such as a surgical device, surgicalfastener, clip, tack, bougie, band, and/or plate, for example. Examplecritical structures are further described herein and in theaforementioned U.S. Patent Applications, including U.S. patentapplication Ser. No. 16/128,192, titled VISUALIZATION OF SURGICALDEVICES, filed Sep. 11, 2018, which issued on Oct. 6, 2020 as U.S. Pat.No. 10,792,034, for example, which are incorporated by reference hereinin their respective entireties.

In one aspect, the critical structure 101 may be embedded in tissue 103.Stated differently, the critical structure 101 may be positioned belowthe surface 105 of the tissue 103. In such instances, the tissue 103conceals the critical structure 101 from the clinician's view. Thecritical structure 101 is also obscured from the view of the imagingdevice 120 by the tissue 103. The tissue 103 can be fat, connectivetissue, adhesions, and/or organs, for example. In other instances, thecritical structure 101 can be partially obscured from view.

FIG. 1 also depicts the surgical device 102. The surgical device 102includes an end effector having opposing jaws extending from the distalend of the shaft of the surgical device 102. The surgical device 102 canbe any suitable surgical device such as, for example, a dissector, astapler, a grasper, a clip applier, and/or an energy device includingmono-polar probes, bi-polar probes, ablation probes, and/or anultrasonic end effector. Additionally or alternatively, the surgicaldevice 102 can include another imaging or diagnostic modality, such asan ultrasound device, for example. In one aspect of the presentdisclosure, the surgical visualization system 100 can be configured toachieve identification of one or more critical structures 101 and theproximity of the surgical device 102 to the critical structure(s) 101.

The imaging device 120 of the surgical visualization system 100 isconfigured to detect light at various wavelengths, such as, for example,visible light, spectral light waves (visible or invisible), and astructured light pattern (visible or invisible). The imaging device 120may include a plurality of lenses, sensors, and/or receivers fordetecting the different signals. For example, the imaging device 120 canbe a hyperspectral, multispectral, or selective spectral camera, asfurther described herein. The imaging device 120 can also include awaveform sensor 122 (such as a spectral image sensor, detector, and/orthree-dimensional camera lens). For example, the imaging device 120 caninclude a right-side lens and a left-side lens used together to recordtwo two-dimensional images at the same time and, thus, generate athree-dimensional image of the surgical site, render a three-dimensionalimage of the surgical site, and/or determine one or more distances atthe surgical site. Additionally or alternatively, the imaging device 120can be configured to receive images indicative of the topography of thevisible tissue and the identification and position of hidden criticalstructures, as further described herein. For example, the field of viewof the imaging device 120 can overlap with a pattern of light(structured light) on the surface 105 of the tissue, as shown in FIG. 1.

In one aspect, the surgical visualization system 100 may be incorporatedinto a robotic system 110. For example, the robotic system 110 mayinclude a first robotic arm 112 and a second robotic arm 114. Therobotic arms 112, 114 include rigid structural members 116 and joints118, which can include servomotor controls. The first robotic arm 112 isconfigured to maneuver the surgical device 102, and the second roboticarm 114 is configured to maneuver the imaging device 120. A roboticcontrol unit can be configured to issue control motions to the roboticarms 112, 114, which can affect the surgical device 102 and the imagingdevice 120, for example.

The surgical visualization system 100 also includes an emitter 106,which is configured to emit a pattern of light, such as stripes, gridlines, and/or dots, to enable the determination of the topography orlandscape of the surface 105. For example, projected light arrays 130can be used for three-dimensional scanning and registration on thesurface 105. The projected light arrays 130 can be emitted from theemitter 106 located on the surgical device 102 and/or one of the roboticarms 112, 114 and/or the imaging device 120, for example. In one aspect,the projected light array 130 is employed to determine the shape definedby the surface 105 of the tissue 103 and/or the motion of the surface105 intraoperatively. The imaging device 120 is configured to detect theprojected light arrays 130 reflected from the surface 105 to determinethe topography of the surface 105 and various distances with respect tothe surface 105.

In one aspect, the imaging device 120 also may include an opticalwaveform emitter 123 that is configured to emit electromagneticradiation 124 (NIR photons) that can penetrate the surface 105 of thetissue 103 and reach the critical structure 101. The imaging device 120and the optical waveform emitter 123 thereon can be positionable by therobotic arm 114. A corresponding waveform sensor 122 (an image sensor,spectrometer, or vibrational sensor, for example) on the imaging device120 is configured to detect the effect of the electromagnetic radiationreceived by the waveform sensor 122. The wavelengths of theelectromagnetic radiation 124 emitted by the optical waveform emitter123 can be configured to enable the identification of the type ofanatomical and/or physical structure, such as the critical structure101. The identification of the critical structure 101 can beaccomplished through spectral analysis, photo-acoustics, and/orultrasound, for example. In one aspect, the wavelengths of theelectromagnetic radiation 124 may be variable. The waveform sensor 122and optical waveform emitter 123 may be inclusive of a multispectralimaging system and/or a selective spectral imaging system, for example.In other instances, the waveform sensor 122 and optical waveform emitter123 may be inclusive of a photoacoustic imaging system, for example. Inother instances, the optical waveform emitter 123 can be positioned on aseparate surgical device from the imaging device 120.

The surgical visualization system 100 also may include the distancesensor system 104 configured to determine one or more distances at thesurgical site. In one aspect, the time-of-flight distance sensor system104 may be a time-of-flight distance sensor system that includes anemitter, such as the emitter 106, and a receiver 108, which can bepositioned on the surgical device 102. In other instances, thetime-of-flight emitter can be separate from the structured lightemitter. In one general aspect, the emitter 106 portion of thetime-of-flight distance sensor system 104 may include a very tiny lasersource and the receiver 108 portion of the time-of-flight distancesensor system 104 may include a matching sensor. The time-of-flightdistance sensor system 104 can detect the “time of flight,” or how longthe laser light emitted by the emitter 106 has taken to bounce back tothe sensor portion of the receiver 108. Use of a very narrow lightsource in the emitter 106 enables the distance sensor system 104 todetermining the distance to the surface 105 of the tissue 103 directlyin front of the distance sensor system 104. Referring still to FIG. 1,d_(e) is the emitter-to-tissue distance from the emitter 106 to thesurface 105 of the tissue 103 and d_(t) is the device-to-tissue distancefrom the distal end of the surgical device 102 to the surface 105 of thetissue. The distance sensor system 104 can be employed to determine theemitter-to-tissue distance d_(e). The device-to-tissue distance d_(t) isobtainable from the known position of the emitter 106 on the shaft ofthe surgical device 102 relative to the distal end of the surgicaldevice 102. In other words, when the distance between the emitter 106and the distal end of the surgical device 102 is known, thedevice-to-tissue distance d_(t) can be determined from theemitter-to-tissue distance d_(e). In certain instances, the shaft of thesurgical device 102 can include one or more articulation joints, and canbe articulatable with respect to the emitter 106 and the jaws. Thearticulation configuration can include a multi-joint vertebrae-likestructure, for example. In certain instances, a three-dimensional cameracan be utilized to triangulate one or more distances to the surface 105.

In various instances, the receiver 108 for the time-of-flight distancesensor system 104 can be mounted on a separate surgical device insteadof the surgical device 102. For example, the receiver 108 can be mountedon a cannula or trocar through which the surgical device 102 extends toreach the surgical site. In still other instances, the receiver 108 forthe time-of-flight distance sensor system 104 can be mounted on aseparate robotically-controlled arm (e.g. the robotic arm 114), on amovable arm that is operated by another robot, and/or to an operatingroom (OR) table or fixture. In certain instances, the imaging device 120includes the time-of-flight receiver 108 to determine the distance fromthe emitter 106 to the surface 105 of the tissue 103 using a linebetween the emitter 106 on the surgical device 102 and the imagingdevice 120. For example, the distance d_(e) can be triangulated based onknown positions of the emitter 106 (on the surgical device 102) and thereceiver 108 (on the imaging device 120) of the time-of-flight distancesensor system 104. The three-dimensional position of the receiver 108can be known and/or registered to the robot coordinate planeintraoperatively.

In certain instances, the position of the emitter 106 of thetime-of-flight distance sensor system 104 can be controlled by the firstrobotic arm 112 and the position of the receiver 108 of thetime-of-flight distance sensor system 104 can be controlled by thesecond robotic arm 114. In other instances, the surgical visualizationsystem 100 can be utilized apart from a robotic system. In suchinstances, the distance sensor system 104 can be independent of therobotic system.

In certain instances, one or more of the robotic arms 112, 114 may beseparate from a main robotic system used in the surgical procedure. Atleast one of the robotic arms 112, 114 can be positioned and registeredto a particular coordinate system without a servomotor control. Forexample, a closed-loop control system and/or a plurality of sensors forthe robotic arms 110 can control and/or register the position of therobotic arm(s) 112, 114 relative to the particular coordinate system.Similarly, the position of the surgical device 102 and the imagingdevice 120 can be registered relative to a particular coordinate system.

Referring still to FIG. 1, d_(w) is the camera-to-critical structuredistance from the optical waveform emitter 123 located on the imagingdevice 120 to the surface of the critical structure 101, and d_(A) isthe depth of the critical structure 101 below the surface 105 of thetissue 103 (i.e., the distance between the portion of the surface 105closest to the surgical device 102 and the critical structure 101). Invarious aspects, the time-of-flight of the optical waveforms emittedfrom the optical waveform emitter 123 located on the imaging device 120can be configured to determine the camera-to-critical structure distanced_(w). The use of spectral imaging in combination with time-of-flightsensors is further described herein. Moreover, referring now to FIG. 3,in various aspects of the present disclosure, the depth d_(A) of thecritical structure 101 relative to the surface 105 of the tissue 103 canbe determined by triangulating from the distance d_(w) and knownpositions of the emitter 106 on the surgical device 102 and the opticalwaveform emitter 123 on the imaging device 120 (and, thus, the knowndistance d_(x) therebetween) to determine the distance d_(y), which isthe sum of the distances d_(e) and d_(A).

Additionally or alternatively, time-of-flight from the optical waveformemitter 123 can be configured to determine the distance from the opticalwaveform emitter 123 to the surface 105 of the tissue 103. For example,a first waveform (or range of waveforms) can be utilized to determinethe camera-to-critical structure distance d_(w) and a second waveform(or range of waveforms) can be utilized to determine the distance to thesurface 105 of the tissue 103. In such instances, the differentwaveforms can be utilized to determine the depth of the criticalstructure 101 below the surface 105 of the tissue 103.

Additionally or alternatively, in certain instances, the distance d_(A)can be determined from an ultrasound, a registered magnetic resonanceimaging (MRI) or computerized tomography (CT) scan. In still otherinstances, the distance d_(A) can be determined with spectral imagingbecause the detection signal received by the imaging device can varybased on the type of material. For example, fat can decrease thedetection signal in a first way, or a first amount, and collagen candecrease the detection signal in a different, second way, or a secondamount.

Referring now to a surgical visualization system 160 in FIG. 4, in whicha surgical device 162 includes the optical waveform emitter 123 and thewaveform sensor 122 that is configured to detect the reflectedwaveforms. The optical waveform emitter 123 can be configured to emitwaveforms for determining the distances d_(t) and d_(w) from a commondevice, such as the surgical device 162, as further described herein. Insuch instances, the distance d_(A) from the surface 105 of the tissue103 to the surface of the critical structure 101 can be determined asfollows:

d _(A) =d _(w) −d _(t).

As disclosed herein, various information regarding visible tissue,embedded critical structures, and surgical devices can be determined byutilizing a combination approach that incorporates one or moretime-of-flight distance sensors, spectral imaging, and/or structuredlight arrays in combination with an image sensor configured to detectthe spectral wavelengths and the structured light arrays. Moreover, theimage sensor can be configured to receive visible light and, thus,provide images of the surgical site to an imaging system. Logic oralgorithms are employed to discern the information received from thetime-of-flight sensors, spectral wavelengths, structured light, andvisible light and render three-dimensional images of the surface tissueand underlying anatomical structures. In various instances, the imagingdevice 120 can include multiple image sensors.

The camera-to-critical structure distance d_(w) can also be detected inone or more alternative ways. In one aspect, a fluoroscopy visualizationtechnology, such as fluorescent indosciedine green (ICG), for example,can be utilized to illuminate a critical structure 201, as shown inFIGS. 6-8. A camera 220 can include two optical waveforms sensors 222,224, which take simultaneous left-side and right-side images of thecritical structure 201 (FIGS. 7A and 7B). In such instances, the camera220 can depict a glow of the critical structure 201 below the surface205 of the tissue 203, and the distance d_(w) can be determined by theknown distance between the sensors 222 and 224. In certain instances,distances can be determined more accurately by utilizing more than onecamera or by moving a camera between multiple locations. In certainaspects, one camera can be controlled by a first robotic arm and asecond camera by another robotic arm. In such a robotic system, onecamera can be a follower camera on a follower arm, for example. Thefollower arm, and camera thereon, can be programmed to track the othercamera and to maintain a particular distance and/or lens angle, forexample.

In still other aspects, the surgical visualization system 100 may employtwo separate waveform receivers (i.e. cameras/image sensors) todetermine d_(w). Referring now to FIG. 9, if a critical structure 301 orthe contents thereof (e.g. a vessel or the contents of the vessel) canemit a signal 302, such as with fluoroscopy, then the actual locationcan be triangulated from two separate cameras 320 a, 320 b at knownlocations.

In another aspect, referring now to FIGS. 10A and 10B, a surgicalvisualization system may employ a dithering or moving camera 440 todetermine the distance d_(w). The camera 440 is robotically-controlledsuch that the three-dimensional coordinates of the camera 440 at thedifferent positions are known. In various instances, the camera 440 canpivot at a cannula or patient interface. For example, if a criticalstructure 401 or the contents thereof (e.g. a vessel or the contents ofthe vessel) can emit a signal, such as with fluoroscopy, for example,then the actual location can be triangulated from the camera 440 movedrapidly between two or more known locations. In FIG. 10A, the camera 440is moved axially along an axis A. More specifically, the camera 440translates a distance d₁ closer to the critical structure 401 along theaxis A to the location indicated as a location 440′, such as by movingin and out on a robotic arm. As the camera 440 moves the distance d₁ andthe size of view change with respect to the critical structure 401, thedistance to the critical structure 401 can be calculated. For example, a4.28 mm axial translation (the distance d₁) can correspond to an angleθ₁ of 6.28 degrees and an angle θ₂ of 8.19 degrees. Additionally oralternatively, the camera 440 can rotate or sweep along an arc betweendifferent positions. Referring now to FIG. 10B, the camera 440 is movedaxially along the axis A and is rotated an angle θ₃ about the axis A. Apivot point 442 for rotation of the camera 440 is positioned at thecannula/patient interface. In FIG. 10B, the camera 440 is translated androtated to a location 440″. As the camera 440 moves and the edge of viewchanges with respect to the critical structure 401, the distance to thecritical structure 401 can be calculated. In FIG. 10B, a distance d₂ canbe 9.01 mm, for example, and the angle θ₃ can be 0.9 degrees, forexample.

FIG. 5 depicts a surgical visualization system 500, which is similar tothe surgical visualization system 100 in many respects. In variousinstances, the surgical visualization system 500 can be a furtherexemplification of the surgical visualization system 100. Similar to thesurgical visualization system 100, the surgical visualization system 500includes a surgical device 502 and an imaging device 520. The imagingdevice 520 includes a spectral light emitter 523, which is configured toemit spectral light in a plurality of wavelengths to obtain a spectralimage of hidden structures, for example. The imaging device 520 can alsoinclude a three-dimensional camera and associated electronic processingcircuits in various instances. The surgical visualization system 500 isshown being utilized intraoperatively to identify and facilitateavoidance of certain critical structures, such as a ureter 501 a andvessels 501 b in an organ 503 (the uterus in this example), that are notvisible on the surface.

The surgical visualization system 500 is configured to determine anemitter-to-tissue distance d_(e) from an emitter 506 on the surgicaldevice 502 to a surface 505 of the uterus 503 via structured light. Thesurgical visualization system 500 is configured to extrapolate adevice-to-tissue distance d_(t) from the surgical device 502 to thesurface 505 of the uterus 503 based on the emitter-to-tissue distanced_(e). The surgical visualization system 500 is also configured todetermine a tissue-to-ureter distance d_(A) from the ureter 501 a to thesurface 505 and a camera-to ureter distance d_(w) from the imagingdevice 520 to the ureter 501 a. As described herein with respect to FIG.1, for example, the surgical visualization system 500 can determine thedistance d_(w) with spectral imaging and time-of-flight sensors, forexample. In various instances, the surgical visualization system 500 candetermine (e.g. triangulate) the tissue-to-ureter distance d_(A) (ordepth) based on other distances and/or the surface mapping logicdescribed herein.

Referring now to FIG. 11, where a schematic of a control system 600 fora surgical visualization system, such as the surgical visualizationsystem 100, for example, is depicted. The control system 600 is aconversion system that integrates spectral signature tissueidentification and structured light tissue positioning to identifycritical structures, especially when those structures are obscured byother tissue, such as fat, connective tissue, blood, and/or otherorgans, for example. Such technology could also be useful for detectingtissue variability, such as differentiating tumors and/or non-healthytissue from healthy tissue within an organ.

The control system 600 is configured for implementing a hyperspectralimaging and visualization system in which a molecular response isutilized to detect and identify anatomy in a surgical field of view. Thecontrol system 600 includes a conversion logic circuit 648 to converttissue data to surgeon usable information. For example, the variablereflectance based on wavelengths with respect to obscuring material canbe utilized to identify the critical structure in the anatomy. Moreover,the control system 600 combines the identified spectral signature andthe structural light data in an image. For example, the control system600 can be employed to create of three-dimensional data set for surgicaluse in a system with augmentation image overlays. Techniques can beemployed both intraoperatively and preoperatively using additionalvisual information. In various instances, the control system 600 isconfigured to provide warnings to a clinician when in the proximity ofone or more critical structures. Various algorithms can be employed toguide robotic automation and semi-automated approaches based on thesurgical procedure and proximity to the critical structure(s).

A projected array of lights is employed to determine tissue shape andmotion intraoperatively. Alternatively, flash Lidar may be utilized forsurface mapping of the tissue.

The control system 600 is configured to detect the critical structure(s)and provide an image overlay of the critical structure and measure thedistance to the surface of the visible tissue and the distance to theembedded/buried critical structure(s). In other instances, the controlsystem 600 can measure the distance to the surface of the visible tissueor detect the critical structure(s) and provide an image overlay of thecritical structure.

The control system 600 includes a spectral control circuit 602. Thespectral control circuit 602 can be a field programmable gate array(FPGA) or another suitable circuit configuration as described herein inconnection with FIGS. 2A-2C, for example. The spectral control circuit602 includes a processor 604 to receive video input signals from a videoinput processor 606. The processor 604 can be configured forhyperspectral processing and can utilize C/C++ code, for example. Thevideo input processor 606 receives video-in of control (metadata) datasuch as shutter time, wave length, and sensor analytics, for example.The processor 604 is configured to process the video input signal fromthe video input processor 606 and provide a video output signal to avideo output processor 608, which includes a hyperspectral video-out ofinterface control (metadata) data, for example. The video outputprocessor 608 provides the video output signal to an image overlaycontroller 610.

The video input processor 606 is coupled to a camera 612 at the patientside via a patient isolation circuit 614. As previously discussed, thecamera 612 includes a solid state image sensor 634. The patientisolation circuit can include a plurality of transformers so that thepatient is isolated from other circuits in the system. The camera 612receives intraoperative images through optics 632 and the image sensor634. The image sensor 634 can include a CMOS image sensor, for example,or may include any of the image sensor technologies discussed herein inconnection with FIG. 2, for example. In one aspect, the camera 612outputs images in 14 bit/pixel signals. It will be appreciated thathigher or lower pixel resolutions may be employed without departing fromthe scope of the present disclosure. The isolated camera output signal613 is provided to a color RGB fusion circuit 616, which employs ahardware register 618 and a Nios2 co-processor 620 to process the cameraoutput signal 613. A color RGB fusion output signal is provided to thevideo input processor 606 and a laser pulsing control circuit 622.

The laser pulsing control circuit 622 controls a laser light engine 624.The laser light engine 624 outputs light in a plurality of wavelengths(λ₁, λ₂, λ₃ . . . λ_(n)) including near infrared (NIR). The laser lightengine 624 can operate in a plurality of modes. In one aspect, the laserlight engine 624 can operate in two modes, for example. In a first mode,e.g. a normal operating mode, the laser light engine 624 outputs anilluminating signal. In a second mode, e.g. an identification mode, thelaser light engine 624 outputs RGBG and NIR light. In various instances,the laser light engine 624 can operate in a polarizing mode.

Light output 626 from the laser light engine 624 illuminates targetedanatomy in an intraoperative surgical site 627. The laser pulsingcontrol circuit 622 also controls a laser pulse controller 628 for alaser pattern projector 630 that projects a laser light pattern 631,such as a grid or pattern of lines and/or dots, at a predeterminedwavelength (λ₂) on the operative tissue or organ at the surgical site627. The camera 612 receives the patterned light as well as thereflected light output through the camera optics 632. The image sensor634 converts the received light into a digital signal.

The color RGB fusion circuit 616 also outputs signals to the imageoverlay controller 610 and a video input module 636 for reading thelaser light pattern 631 projected onto the targeted anatomy at thesurgical site 627 by the laser pattern projector 630. A processingmodule 638 processes the laser light pattern 631 and outputs a firstvideo output signal 640 representative of the distance to the visibletissue at the surgical site 627. The data is provided to the imageoverlay controller 610. The processing module 638 also outputs a secondvideo signal 642 representative of a three-dimensional rendered shape ofthe tissue or organ of the targeted anatomy at the surgical site.

The first and second video output signals 640, 642 include datarepresentative of the position of the critical structure on athree-dimensional surface model, which is provided to an integrationmodule 643. In combination with data from the video out processor 608 ofthe spectral control circuit 602, the integration module 643 candetermine the distance d_(A) (FIG. 1) to a buried critical structure(e.g. via triangularization algorithms 644), and the distance d_(A) canbe provided to the image overlay controller 610 via a video outprocessor 646. The foregoing conversion logic can encompass theconversion logic circuit 648 intermediate video monitors 652 and thecamera 624/laser pattern projector 630 positioned at the surgical site627.

Preoperative data 650 from a CT or MRI scan can be employed to registeror align certain three-dimensional deformable tissue in variousinstances. Such preoperative data 650 can be provided to the integrationmodule 643 and ultimately to the image overlay controller 610 so thatsuch information can be overlaid with the views from the camera 612 andprovided to the video monitors 652. Registration of preoperative data isfurther described herein and in the aforementioned U.S. PatentApplications, including U.S. patent application Ser. No. 16/128,195,titled INTEGRATION OF IMAGING DATA, filed Sep. 11, 2018, now U.S. PatentApplication Publication No. 2020/0015907, for example, which areincorporated by reference herein in their respective entireties.

The video monitors 652 can output the integrated/augmented views fromthe image overlay controller 610. A clinician can select and/or togglebetween different views on one or more monitors. On a first monitor 652a, the clinician can toggle between (A) a view in which athree-dimensional rendering of the visible tissue is depicted and (B) anaugmented view in which one or more hidden critical structures aredepicted over the three-dimensional rendering of the visible tissue. Ona second monitor 652 b, the clinician can toggle on distancemeasurements to one or more hidden critical structures and/or thesurface of visible tissue, for example.

The control system 600 and/or various control circuits thereof can beincorporated into various surgical visualization systems disclosedherein.

FIG. 12 illustrates a structured (or patterned) light system 700,according to at least one aspect of the present disclosure. As describedherein, structured light in the form of stripes or lines, for example,can be projected from a light source and/or projector 706 onto thesurface 705 of targeted anatomy to identify the shape and contours ofthe surface 705. A camera 720, which can be similar in various respectsto the imaging device 120 (FIG. 1), for example, can be configured todetect the projected pattern of light on the surface 705. The way thatthe projected pattern deforms upon striking the surface 705 allowsvision systems to calculate the depth and surface information of thetargeted anatomy.

In certain instances, invisible (or imperceptible) structured light canbe utilized, in which the structured light is used without interferingwith other computer vision tasks for which the projected pattern may beconfusing. For example, infrared light or extremely fast frame rates ofvisible light that alternate between two exact opposite patterns can beutilized to prevent interference. Structured light is further describedat en.wikipedia.org/wiki/Structured_light.

As noted above, the various surgical visualization systems describedherein can be utilized to visualize various different types of tissuesand/or anatomical structures, including tissues and/or anatomicalstructures that may be obscured from being visualized by EMR in thevisible portion of the spectrum. In one aspect, the surgicalvisualization systems can utilize a spectral imaging system to visualizedifferent types of tissues based upon their varying combinations ofconstituent materials. In particular, a spectral imaging system can beconfigured to detect the presence of various constituent materialswithin a tissue being visualized based on the absorption coefficient ofthe tissue across various EMR wavelengths. The spectral imaging systemcan be further configured to characterize the tissue type of the tissuebeing visualized based upon the particular combination of constituentmaterials. To illustrate, FIG. 13A is a graph 2300 depicting how theabsorption coefficient of various biological materials varies across theEMR wavelength spectrum. In the graph 2300, the vertical axis 2303represents absorption coefficient of the biological material (e.g., incm⁻¹) and the horizontal axis 2304 represents EMR wavelength (e.g., inμm). The graph 2300 further illustrates a first line 2310 representingthe absorption coefficient of water at various EMR wavelengths, a secondline 2312 representing the absorption coefficient of protein at variousEMR wavelengths, a third line 2314 representing the absorptioncoefficient of melanin at various EMR wavelengths, a fourth line 2316representing the absorption coefficient of deoxygenated hemoglobin atvarious EMR wavelengths, a fifth line 2318 representing the absorptioncoefficient of oxygenated hemoglobin at various EMR wavelengths, and asixth line 2319 representing the absorption coefficient of collagen atvarious EMR wavelengths. Different tissue types have differentcombinations of constituent materials and, therefore, the tissue type(s)being visualized by a surgical visualization system can be identifiedand differentiated between according to the particular combination ofdetected constituent materials. Accordingly, a spectral imaging systemcan be configured to emit EMR at a number of different wavelengths,determine the constituent materials of the tissue based on the detectedabsorption EMR absorption response at the different wavelengths, andthen characterize the tissue type based on the particular detectedcombination of constituent materials.

An illustration of the utilization of spectral imaging techniques tovisualize different tissue types and/or anatomical structures is shownin FIG. 13B. In FIG. 13B, a spectral emitter 2320 (e.g., spectral lightsource 150) is being utilized by an imaging system to visualize asurgical site 2325. The EMR emitted by the spectral emitter 2320 andreflected from the tissues and/or structures at the surgical site 2325can be received by an image sensor 135 (FIG. 2) to visualize the tissuesand/or structures, which can be either visible (e.g., be located at thesurface of the surgical site 2325) or obscured (e.g., underlay othertissue and/or structures at the surgical site 2325). In this example, animaging system 142 (FIG. 2) can visualize a tumor 2332, an artery 2334,and various abnormalities 2338 (i.e., tissues not confirming to known orexpected spectral signatures) based upon the spectral signaturescharacterized by the differing absorptive characteristics (e.g.,absorption coefficient) of the constituent materials for each of thedifferent tissue/structure types. The visualized tissues and structurescan be displayed on a display screen associated with or coupled to theimaging system 142, such as an imaging system display 146 (FIG. 2), aprimary display 2119 (FIG. 18), a non-sterile display 2109 (FIG. 18), ahub display 2215 (FIG. 19), a device/instrument display 2237 (FIG. 19),and so on.

Further, the imaging system 142 can be configured to tailor or updatethe displayed surgical site visualization according to the identifiedtissue and/or structure types. For example, the imaging system 142 candisplay a margin 2330 a associated with the tumor 2332 being visualizedon a display screen (e.g., display 146). The margin 2330 a can indicatethe area or amount of tissue that should be excised to ensure completeremoval of the tumor 2332. The control system 133 (FIG. 2) can beconfigured to control or update the dimensions of the margin 2330 abased on the tissues and/or structures identified by the imaging system142. In the illustrated example, the imaging system 142 has identifiedmultiple abnormalities 2338 within the FOV. Accordingly, the controlsystem 133 can adjust the displayed margin 2330 a to a first updatedmargin 2330 b having sufficient dimensions to encompass theabnormalities 2338. Further, the imaging system 142 has also identifiedan artery 2334 partially overlapping with the initially displayed margin2330 a (as indicated by the highlighted region 2336 of the artery 2334).Accordingly, the control system 133 can adjust the displayed margin 2330a to a second updated margin 2330 c having sufficient dimensions toencompass the relevant portion of the artery 2334.

Tissues and/or structures can also be imaged or characterized accordingto their reflective characteristics, in addition to or in lieu of theirabsorptive characteristics described above with respect to FIGS. 13A and13B, across the EMR wavelength spectrum. For example, FIGS. 13C-13Eillustrate various graphs of reflectance of different types of tissuesor structures across different EMR wavelengths. FIG. 13C is a graphicalrepresentation 1050 of an illustrative ureter signature versusobscurants. FIG. 13D is a graphical representation 1052 of anillustrative artery signature versus obscurants. FIG. 13E is a graphicalrepresentation 1054 of an illustrative nerve signature versusobscurants. The plots in FIGS. 13C-13E represent reflectance as afunction of wavelength (nm) for the particular structures (ureter,artery, and nerve) relative to the corresponding reflectances of fat,lung tissue, and blood at the corresponding wavelengths. These graphsare simply for illustrative purposes and it should be understood thatother tissues and/or structures could have corresponding detectablereflectance signatures that would allow the tissues and/or structures tobe identified and visualized.

In various instances, select wavelengths for spectral imaging can beidentified and utilized based on the anticipated critical structuresand/or obscurants at a surgical site (i.e., “selective spectral”imaging). By utilizing selective spectral imaging, the amount of timerequired to obtain the spectral image can be minimized such that theinformation can be obtained in real-time, or near real-time, andutilized intraoperatively. In various instances, the wavelengths can beselected by a clinician or by a control circuit based on input by theclinician. In certain instances, the wavelengths can be selected basedon machine learning and/or big data accessible to the control circuitvia a cloud, for example.

The foregoing application of spectral imaging to tissue can be utilizedintraoperatively to measure the distance between a waveform emitter anda critical structure that is obscured by tissue. In one aspect of thepresent disclosure, referring now to FIGS. 14 and 15, a time-of-flightsensor system 1104 utilizing waveforms 1124, 1125 is shown. Thetime-of-flight sensor system 1104 can be incorporated into the surgicalvisualization system 100 (FIG. 1) in certain instances. Thetime-of-flight sensor system 1104 includes a waveform emitter 1106 and awaveform receiver 1108 on the same surgical device 1102. The emittedwave 1124 extends to the critical structure 1101 from the emitter 1106and the received wave 1125 is reflected back to by the receiver 1108from the critical structure 1101. The surgical device 1102 is positionedthrough a trocar 1110 that extends into a cavity 1107 in a patient.

The waveforms 1124, 1125 are configured to penetrate obscuring tissue1103. For example, the wavelengths of the waveforms 1124, 1125 can be inthe NIR or SWIR spectrum of wavelengths. In one aspect, a spectralsignal (e.g. hyperspectral, multispectral, or selective spectral) or aphotoacoustic signal can be emitted from the emitter 1106 and canpenetrate the tissue 1103 in which the critical structure 1101 isconcealed. The emitted waveform 1124 can be reflected by the criticalstructure 1101. The received waveform 1125 can be delayed due to thedistance d between the distal end of the surgical device 1102 and thecritical structure 1101. In various instances, the waveforms 1124, 1125can be selected to target the critical structure 1101 within the tissue1103 based on the spectral signature of the critical structure 1101, asfurther described herein. In various instances, the emitter 1106 isconfigured to provide a binary signal on and off, as shown in FIG. 15,for example, which can be measured by the receiver 1108.

Based on the delay between the emitted wave 1124 and the received wave1125, the time-of-flight sensor system 1104 is configured to determinethe distance d (FIG. 14). A time-of-flight timing diagram 1130 for theemitter 1106 and the receiver 1108 of FIG. 14 is shown in FIG. 15. Thedelay is a function of the distance d and the distance d is given by:

$d = {\frac{ct}{2} \cdot \frac{q_{2}}{q_{1} + q_{2}}}$

where:

c=the speed of light;

t=length of pulse;

q₁=accumulated charge while light is emitted; and

q₂=accumulated charge while light is not being emitted.

As provided herein, the time-of-flight of the waveforms 1124, 1125corresponds to the distance din FIG. 14. In various instances,additional emitters/receivers and/or pulsing signals from the emitter1106 can be configured to emit a non-penetrating signal. Thenon-penetrating tissue can be configured to determine the distance fromthe emitter to the surface 1105 of the obscuring tissue 1103. In variousinstances, the depth of the critical structure 1101 can be determinedby:

d _(A) =d _(w) −d _(t).

where:

d_(A)=the depth of the critical structure 1101;

d_(w)=the distance from the emitter 1106 to the critical structure 1101(din FIG. 14); and

d_(t,)=the distance from the emitter 1106 (on the distal end of thesurgical device 1102) to the surface 1105 of the obscuring tissue 1103.

In one aspect of the present disclosure, referring now to FIG. 16, atime-of-flight sensor system 1204 utilizing waves 1224 a, 1224 b, 1224c, 1225 a, 1225 b, 1225 c is shown. The time-of-flight sensor system1204 can be incorporated into the surgical visualization system 100(FIG. 1) in certain instances. The time-of-flight sensor system 1204includes a waveform emitter 1206 and a waveform receiver 1208. Thewaveform emitter 1206 is positioned on a first surgical device 1202 a,and the waveform receiver 1208 is positioned on a second surgical device1202 b. The surgical devices 1202 a, 1202 b are positioned through theirrespective trocars 1210 a, 1210 b, respectively, which extend into acavity 1207 in a patient. The emitted waves 1224 a, 1224 b, 1224 cextend toward a surgical site from the emitter 1206 and the receivedwaves 1225 a, 1225 b, 1225 c are reflected back to the -receiver 1208from various structures and/or surfaces at the surgical site.

The different emitted waves 1224 a, 1224 b, 1224 c are configured totarget different types of material at the surgical site. For example,the wave 1224 a targets the obscuring tissue 1203, the wave 1224 btargets a first critical structure 1201 a (e.g. a vessel), and the wave1224 c targets a second critical structure 1201 b (e.g. a canceroustumor). The wavelengths of the waves 1224 a, 1224 b, 1224 c can be inthe visible light, NIR, or SWIR spectrum of wavelengths. For example,visible light can be reflected off a surface 1205 of the tissue 1203 andNIR and/or SWIR waveforms can be configured to penetrate the surface1205 of the tissue 1203. In various aspects, as described herein, aspectral signal (e.g. hyperspectral, multispectral, or selectivespectral) or a photoacoustic signal can be emitted from the emitter1206. In various instances, the waves 1224 b, 1224 c can be selected totarget the critical structures 1201 a, 1201 b within the tissue 1203based on the spectral signature of the critical structure 1201 a, 1201b, as further described herein. Photoacoustic imaging is furtherdescribed in various U.S. Patent Applications, which are incorporated byreference herein in the present disclosure.

The emitted waves 1224 a, 1224 b, 1224 c can be reflected off thetargeted material (i.e. the surface 1205, the first critical structure1201 a, and the second structure 1201 b, respectively). The receivedwaveforms 1225 a, 1225 b, 1225 c can be delayed due to the distancesd_(1a), d_(2a), d_(3a), d_(1b), d_(2b), d_(2c) indicated in FIG. 16.

In the time-of-flight sensor system 1204, in which the emitter 1206 andthe receiver 1208 are independently positionable (e.g., on separatesurgical devices 1202 a, 1202 b and/or controlled by separate roboticarms), the various distances d_(1a), d_(2a), d_(3a), d_(1b), d₂b, d_(2c)can be calculated from the known position of the emitter 1206 and thereceiver 1208. For example, the positions can be known when the surgicaldevices 1202 a, 1202 b are robotically-controlled. Knowledge of thepositions of the emitter 1206 and the receiver 1208, as well as the timeof the photon stream to target a certain tissue and the informationreceived by the receiver 1208 of that particular response can allow adetermination of the distances d_(1a), d_(2a), d_(3a), d_(1b), d_(2b),d_(2c). In one aspect, the distance to the obscured critical structures1201 a, 1201 b can be triangulated using penetrating wavelengths.Because the speed of light is constant for any wavelength of visible orinvisible light, the time-of-flight sensor system 1204 can determine thevarious distances.

Referring still to FIG. 16, in various instances, in the view providedto the clinician, the receiver 1208 can be rotated such that the centerof mass of the target structure in the resulting images remainsconstant, i.e., in a plane perpendicular to the axis of a select targetstructures 1203, 1201 a, or 1201 b. Such an orientation can quicklycommunicate one or more relevant distances and/or perspectives withrespect to the critical structure. For example, as shown in FIG. 16, thesurgical site is displayed from a viewpoint in which the criticalstructure 1201 a is perpendicular to the viewing plane (i.e. the vesselis oriented in/out of the page). In various instances, such anorientation can be default setting; however, the view can be rotated orotherwise adjusted by a clinician. In certain instances, the cliniciancan toggle between different surfaces and/or target structures thatdefine the viewpoint of the surgical site provided by the imagingsystem.

In various instances, the receiver 1208 can be mounted on a trocar orcannula, such as the trocar 1210 b, for example, through which thesurgical device 1202 b is positioned. In other instances, the receiver1208 can be mounted on a separate robotic arm for which thethree-dimensional position is known. In various instances, the receiver1208 can be mounted on a movable arm that is separate from the robotthat controls the surgical device 1202 a or can be mounted to anoperating room (OR) table that is intraoperatively registerable to therobot coordinate plane. In such instances, the position of the emitter1206 and the receiver 1208 can be registerable to the same coordinateplane such that the distances can be triangulated from outputs from thetime-of-flight sensor system 1204.

Combining time-of-flight sensor systems and near-infrared spectroscopy(NIRS), termed TOF-NIRS, which is capable of measuring the time-resolvedprofiles of NIR light with nanosecond resolution can be found in thearticle titled TIME-OF-FLIGHT NEAR-INFRARED SPECTROSCOPY FORNONDESTRUCTIVE MEASUREMENT OF INTERNAL QUALITY IN GRAPEFRUIT, in theJournal of the American Society for Horticultural Science, May 2013 vol.138 no. 3 225-228, which is incorporated by reference herein in itsentirety, and is accessible atjournal.ashspublications.org/content/138/3/225.full.

In various instances, time-of-flight spectral waveforms are configuredto determine the depth of the critical structure and/or the proximity ofa surgical device to the critical structure. Moreover, the varioussurgical visualization systems disclosed herein include surface mappinglogic that is configured to create three-dimensional rendering of thesurface of the visible tissue. In such instances, even when the visibletissue obstructs a critical structure, the clinician can be aware of theproximity (or lack thereof) of a surgical device to the criticalstructure. In one instances, the topography of the surgical site isprovided on a monitor by the surface mapping logic. If the criticalstructure is close to the surface of the tissue, spectral imaging canconvey the position of the critical structure to the clinician. Forexample, spectral imaging may detect structures within 5 or 10 mm of thesurface. In other instances, spectral imaging may detect structures 10or 20 mm below the surface of the tissue. Based on the known limits ofthe spectral imaging system, the system is configured to convey that acritical structure is out-of-range if it is simply not detected by thespectral imaging system. Therefore, the clinician can continue to movethe surgical device and/or manipulate the tissue. When the criticalstructure moves into range of the spectral imaging system, the systemcan identify the structure and, thus, communicate that the structure iswithin range. In such instances, an alert can be provided when astructure is initially identified and/or moved further within apredefined proximity zone. In such instances, even non-identification ofa critical structure by a spectral imaging system with knownbounds/ranges can provide proximity information (i.e. the lack ofproximity) to the clinician.

Various surgical visualization systems disclosed herein can beconfigured to identify intraoperatively the presence of and/or proximityto critical structure(s) and to alert a clinician prior to damaging thecritical structure(s) by inadvertent dissection and/or transection. Invarious aspects, the surgical visualization systems are configured toidentify one or more of the following critical structures: ureters,bowel, rectum, nerves (including the phrenic nerve, recurrent laryngealnerve [RLN], promontory facial nerve, vagus nerve, and branchesthereof), vessels (including the pulmonary and lobar arteries and veins,inferior mesenteric artery [IMA] and branches thereof, superior rectalartery, sigmoidal arteries, and left colic artery), superior mesentericartery (SMA) and branches thereof (including middle colic artery, rightcolic artery, ilecolic artery), hepatic artery and branches thereof,portal vein and branches thereof, splenic artery/vein and branchesthereof, external and internal (hypogastric) ileac vessels, shortgastric arteries, uterine arteries, middle sacral vessels, and lymphnodes, for example. Moreover, the surgical visualization systems areconfigured to indicate proximity of surgical device(s) to the criticalstructure(s) and/or warn the clinician when surgical device(s) aregetting close to the critical structure(s).

Various aspects of the present disclosure provide intraoperativecritical structure identification (e.g., identification of ureters,nerves, and/or vessels) and instrument proximity monitoring. Forexample, various surgical visualization systems disclosed herein caninclude spectral imaging and surgical instrument tracking, which enablethe visualization of critical structures below the surface of thetissue, such as 1.0-1.5 cm below the surface of the tissue, for example.In other instances, the surgical visualization system can identifystructures less than 1.0 cm or more the 1.5 cm below the surface of thetissue. For example, even a surgical visualization system that canidentify structures only within 0.2 mm of the surface, for example, canbe valuable if the structure cannot otherwise be seen due to the depth.In various aspects, the surgical visualization system can augment theclinician's view with a virtual depiction of the critical structure as avisible white-light image overlay on the surface of visible tissue, forexample. The surgical visualization system can provide real-time,three-dimensional spatial tracking of the distal tip of surgicalinstruments and can provide a proximity alert when the distal tip of asurgical instrument moves within a certain range of the criticalstructure, such as within 1.0 cm of the critical structure, for example.

Various surgical visualization systems disclosed herein can identifywhen dissection is too close to a critical structure. Dissection may be“too close” to a critical structure based on the temperature (i.e. toohot within a proximity of the critical structure that may riskdamaging/heating/melting the critical structure) and/or based on tension(i.e. too much tension within a proximity of the critical structure thatmay risk damaging/tearing/pulling the critical structure). Such asurgical visualization system can facilitate dissection around vesselswhen skeletonizing the vessels prior to ligation, for example. Invarious instances, a thermal imaging camera can be utilized to read theheat at the surgical site and provide a warning to the clinician that isbased on the detected heat and the distance from a tool to thestructure. For example, if the temperature of the tool is over apredefined threshold (such as 120 degrees F., for example), an alert canbe provided to the clinician at a first distance (such as 10 mm, forexample), and if the temperature of the tool is less than or equal tothe predefined threshold, the alert can be provided to the clinician ata second distance (such as 5 mm, for example). The predefined thresholdsand/or warning distances can be default settings and/or programmable bythe clinician. Additionally or alternatively, a proximity alert can belinked to thermal measurements made by the tool itself, such as athermocouple that measures the heat in a distal jaw of a monopolar orbipolar dissector or vessel sealer, for example.

Various surgical visualization systems disclosed herein can provideadequate sensitivity with respect to a critical structure andspecificity to enable a clinician to proceed with confidence in a quickbut safe dissection based on the standard of care and/or device safetydata. The system can function intraoperatively and in real-time during asurgical procedure with minimal ionizing radiation risk to a patient ora clinician and, in various instances, no risk of ionizing radiationrisk to the patient or the clinician. Conversely, in a fluoroscopyprocedure, the patient and clinician(s) may be exposed to ionizingradiation via an X-ray beam, for example, that is utilized to view theanatomical structures in real-time.

Various surgical visualization systems disclosed herein can beconfigured to detect and identify one or more desired types of criticalstructures in a forward path of a surgical device, such as when the pathof the surgical device is robotically controlled, for example.Additionally or alternatively, the surgical visualization system can beconfigured to detect and identify one or more types of criticalstructures in a surrounding area of the surgical device and/or inmultiple planes/dimensions, for example.

Various surgical visualization systems disclosed herein can be easy tooperate and/or interpret. Moreover, various surgical visualizationsystems can incorporate an “override” feature that allows the clinicianto override a default setting and/or operation. For example, a cliniciancan selectively turn off alerts from the surgical visualization systemand/or get closer to a critical structure than suggested by the surgicalvisualization system such as when the risk to the critical structure isless than risk of avoiding the area (e.g. when removing cancer around acritical structure the risk of leaving the cancerous tissue can begreater than the risk of damage to the critical structure).

Various surgical visualization systems disclosed herein can beincorporated into a surgical system and/or used during a surgicalprocedure with limited impact to the workflow. In other words,implementation of the surgical visualization system may not change theway the surgical procedure is implemented. Moreover, the surgicalvisualization system can be economical in comparison to the costs of aninadvertent transection. Data indicates the reduction in inadvertentdamage to a critical structure can drive incremental reimbursement.

Various surgical visualization systems disclosed herein can operate inreal-time, or near real-time, and far enough in advance to enable aclinician to anticipate critical structure(s). For example, a surgicalvisualization system can provide enough time to “slow down, evaluate,and avoid” in order to maximize efficiency of the surgical procedure.

Various surgical visualization systems disclosed herein may not requirea contrast agent, or dye, that is injected into tissue. For example,spectral imaging is configured to visualize hidden structuresintraoperatively without the use of a contrast agent or dye. In otherinstances, the contrast agent can be easier to inject into the properlayer(s) of tissue than other visualization systems. The time betweeninjection of the contrast agent and visualization of the criticalstructure can be less than two hours, for example.

Various surgical visualization systems disclosed herein can be linkedwith clinical data and/or device data. For example, data can provideboundaries for how close energy-enabled surgical devices (or otherpotentially damaging devices) should be from tissue that the surgeondoes not want to damage. Any data modules that interface with thesurgical visualization systems disclosed herein can be providedintegrally or separately from a robot to enable use with stand-alonesurgical devices in open or laparoscopic procedures, for example. Thesurgical visualization systems can be compatible with robotic surgicalsystems in various instances. For example, the visualizationimages/information can be displayed in a robotic console.

In various instances, clinicians may not know the location of a criticalstructure with respect to a surgical tool. For example, when a criticalstructure is embedded in tissue, the clinician may be unable toascertain the location of the critical structure. In certain instances,a clinician may want to keep a surgical device outside a range ofpositions surrounding the critical structure and/or away from thevisible tissue covering the hidden critical structure. When the locationof a concealed critical structure is unknown, the clinician may riskmoving too close to the critical structure, which can result ininadvertent trauma and/or dissection of the critical structure and/ortoo much energy, heat, and/or tension in proximity of the criticalstructure. Alternatively, the clinician may stay too far away from asuspected location of the critical structure and risk affecting tissueat a less desirable location in an effort to avoid the criticalstructure.

A surgical visualization system is provided that presents surgicaldevice tracking with respect to one or more critical structures. Forexample, the surgical visualization system can track the proximity of asurgical device with respect to a critical structure. Such tracking canoccur intraoperatively, in real-time, and/or in near real-time. Invarious instances, the tracking data can be provided to the cliniciansvia a display screen (e.g. a monitor) of an imaging system.

In one aspect of the present disclosure, a surgical visualization systemincludes a surgical device comprising an emitter configured to emit astructured light pattern onto a visible surface, an imaging systemcomprising a camera configured to detect an embedded structure and thestructured light pattern on the visible surface, and a control circuitin signal communication with the camera and the imaging system, whereinthe control circuit is configured to determine a distance from thesurgical device to the embedded structure and provide a signal to theimaging system indicative of the distance. For example, the distance canbe determined by computing a distance from the camera to the criticalstructure that is illuminated with fluoroscopy technology and based on athree-dimensional view of the illuminated structure provided by imagesfrom multiple lenses (e.g. a left-side lens and a right-side lens) ofthe camera. The distance from the surgical device to the criticalstructure can be triangulated based on the known positions of thesurgical device and the camera, for example. Alternative means fordetermining the distance to an embedded critical structure are furtherdescribed herein. For example, NIR time-of-flight distance sensors canbe employed. Additionally or alternatively, the surgical visualizationsystem can determine a distance to visible tissue overlying/covering anembedded critical structure. For example, the surgical visualizationsystem can identify a hidden critical structure and augment a view ofthe hidden critical structure by depicting a schematic of the hiddencritical structure on the visible structure, such as a line on thesurface of the visible tissue. The surgical visualization system canfurther determine the distance to the augmented line on the visibletissue.

By providing the clinician with up-to-date information regarding theproximity of the surgical device to the concealed critical structureand/or visible structure, as provided by the various surgicalvisualization systems disclosed herein, the clinician can make moreinformed decisions regarding the placement of the surgical devicerelative to the concealed critical structure. For example, the cliniciancan view the distance between the surgical device and the criticalstructure in real-time/intraoperatively and, in certain instances, analert and/or warning can be provided by the imaging system when thesurgical device is moved within a predefined proximity and/or zone ofthe critical structure. In certain instances, the alert and/or warningcan be provided when the trajectory of the surgical device indicates alikely collision with a “no-fly” zone in the proximity of the criticalstructure (e.g. within 1 mm, 2 mm, 5 mm, 10 mm, 20 mm or more of thecritical structure). In such instances, the clinician can maintainmomentum throughout the surgical procedure without requiring theclinician to monitor a suspected location of the critical structure andthe surgical device's proximity thereto. As a result, certain surgicalprocedures can be performed more quickly, with fewerpauses/interruptions, and/or with improved accuracy and/or certainty,for example. In one aspect, the surgical visualization system can beutilized to detect tissue variability, such as the variability of tissuewithin an organ to differentiate tumors/cancerous tissue/unhealthytissue from healthy tissue. Such a surgical visualization system canmaximize the removal of the unhealthy tissue while minimizing theremoval of the healthy tissue.

Surgical Hub System

The various visualization or imaging systems described herein can beincorporated into a surgical hub system, such as is illustrated inconnection with FIGS. 17-19 and described in further detail below.

Referring to FIG. 17, a computer-implemented interactive surgical system2100 includes one or more surgical systems 2102 and a cloud-based system(e.g., the cloud 2104 that may include a remote server 2113 coupled to astorage device 2105). Each surgical system 2102 includes at least onesurgical hub 2106 in communication with the cloud 2104 that may includea remote server 2113. In one example, as illustrated in FIG. 17, thesurgical system 2102 includes a visualization system 2108, a roboticsystem 2110, and a handheld intelligent surgical instrument 2112, whichare configured to communicate with one another and/or the hub 2106. Insome aspects, a surgical system 2102 may include an M number of hubs2106, an N number of visualization systems 2108, an O number of roboticsystems 2110, and a P number of handheld intelligent surgicalinstruments 2112, where M, N, O, and P are integers greater than orequal to one.

FIG. 18 depicts an example of a surgical system 2102 being used toperform a surgical procedure on a patient who is lying down on anoperating table 2114 in a surgical operating room 2116. A robotic system2110 is used in the surgical procedure as a part of the surgical system2102. The robotic system 2110 includes a surgeon's console 2118, apatient side cart 2120 (surgical robot), and a surgical robotic hub2122. The patient side cart 2120 can manipulate at least one removablycoupled surgical tool 2117 through a minimally invasive incision in thebody of the patient while the surgeon views the surgical site throughthe surgeon's console 2118. An image of the surgical site can beobtained by a medical imaging device 2124, which can be manipulated bythe patient side cart 2120 to orient the imaging device 2124. Therobotic hub 2122 can be used to process the images of the surgical sitefor subsequent display to the surgeon through the surgeon's console2118.

Other types of robotic systems can be readily adapted for use with thesurgical system 2102. Various examples of robotic systems and surgicaltools that are suitable for use with the present disclosure aredescribed in various U.S. Patent Applications, which are incorporated byreference herein in the present disclosure.

Various examples of cloud-based analytics that are performed by thecloud 2104, and are suitable for use with the present disclosure, aredescribed in various U.S. Patent Applications, which are incorporated byreference herein in the present disclosure.

In various aspects, the imaging device 2124 includes at least one imagesensor and one or more optical components. Suitable image sensorsinclude, but are not limited to, Charge-Coupled Device (CCD) sensors andComplementary Metal-Oxide Semiconductor (CMOS) sensors.

The optical components of the imaging device 2124 may include one ormore illumination sources and/or one or more lenses. The one or moreillumination sources may be directed to illuminate portions of thesurgical field. The one or more image sensors may receive lightreflected or refracted from the surgical field, including lightreflected or refracted from tissue and/or surgical instruments.

The one or more illumination sources may be configured to radiateelectromagnetic energy in the visible spectrum as well as the invisiblespectrum. The visible spectrum, sometimes referred to as the opticalspectrum or luminous spectrum, is that portion of the electromagneticspectrum that is visible to (i.e., can be detected by) the human eye andmay be referred to as visible light or simply light. A typical human eyewill respond to wavelengths in air that are from about 380 nm to about750 nm.

The invisible spectrum (i.e., the non-luminous spectrum) is that portionof the electromagnetic spectrum that lies below and above the visiblespectrum (i.e., wavelengths below about 380 nm and above about 750 nm).The invisible spectrum is not detectable by the human eye. Wavelengthsgreater than about 750 nm are longer than the red visible spectrum, andthey become invisible infrared (IR), microwave, and radioelectromagnetic radiation. Wavelengths less than about 380 nm areshorter than the violet spectrum, and they become invisible ultraviolet,x-ray, and gamma ray electromagnetic radiation.

In various aspects, the imaging device 2124 is configured for use in aminimally invasive procedure. Examples of imaging devices suitable foruse with the present disclosure include, but not limited to, anarthroscope, angioscope, bronchoscope, choledochoscope, colonoscope,cytoscope, duodenoscope, enteroscope, esophagogastro-duodenoscope(gastroscope), endoscope, laryngoscope, nasopharyngo-neproscope,sigmoidoscope, thoracoscope, and ureteroscope.

In one aspect, the imaging device employs multi-spectrum monitoring todiscriminate topography and underlying structures. A multi-spectralimage is one that captures image data within specific wavelength rangesacross the electromagnetic spectrum. The wavelengths may be separated byfilters or by the use of instruments that are sensitive to particularwavelengths, including light from frequencies beyond the visible lightrange, e.g., IR and ultraviolet. Spectral imaging can allow extractionof additional information the human eye fails to capture with itsreceptors for red, green, and blue. The use of multi-spectral imaging isdescribed in various U.S. Patent Applications that are incorporated byreference herein in the present disclosure. Multi-spectrum monitoringcan be a useful tool in relocating a surgical field after a surgicaltask is completed to perform one or more of the previously describedtests on the treated tissue.

It is axiomatic that strict sterilization of the operating room andsurgical equipment is required during any surgery. The strict hygieneand sterilization conditions required in a “surgical theater,” i.e., anoperating or treatment room, necessitate the highest possible sterilityof all medical devices and equipment. Part of that sterilization processis the need to sterilize anything that comes in contact with the patientor penetrates the sterile field, including the imaging device 2124 andits attachments and components. It will be appreciated that the sterilefield may be considered a specified area, such as within a tray or on asterile towel, that is considered free of microorganisms, or the sterilefield may be considered an area, immediately around a patient, who hasbeen prepared for a surgical procedure. The sterile field may includethe scrubbed team members, who are properly attired, and all furnitureand fixtures in the area. In various aspects, the visualization system2108 includes one or more imaging sensors, one or more image-processingunits, one or more storage arrays, and one or more displays that arestrategically arranged with respect to the sterile field, as illustratedin FIG. 18. In one aspect, the visualization system 2108 includes aninterface for HL7, PACS, and EMR. Various components of thevisualization system 2108 are described in various U.S. PatentApplications that are incorporated by reference herein in the presentdisclosure.

As illustrated in FIG. 18, a primary display 2119 is positioned in thesterile field to be visible to an operator at the operating table 2114.In addition, a visualization tower 21121 is positioned outside thesterile field. The visualization tower 21121 includes a firstnon-sterile display 2107 and a second non-sterile display 2109, whichface away from each other. The visualization system 2108, guided by thehub 2106, is configured to utilize the displays 2107, 2109, and 2119 tocoordinate information flow to operators inside and outside the sterilefield. For example, the hub 2106 may cause the visualization system 2108to display a snapshot of a surgical site, as recorded by an imagingdevice 2124, on a non-sterile display 2107 or 2109, while maintaining alive feed of the surgical site on the primary display 2119. The snapshoton the non-sterile display 2107 or 2109 can permit a non-sterileoperator to perform a diagnostic step relevant to the surgicalprocedure, for example.

In one aspect, the hub 2106 is also configured to route a diagnosticinput or feedback entered by a non-sterile operator at the visualizationtower 21121 to the primary display 2119 within the sterile field, whereit can be viewed by a sterile operator at the operating table. In oneexample, the input can be in the form of a modification to the snapshotdisplayed on the non-sterile display 2107 or 2109, which can be routedto the primary display 2119 by the hub 2106.

Referring to FIG. 18, a surgical instrument 2112 is being used in thesurgical procedure as part of the surgical system 2102. The hub 2106 isalso configured to coordinate information flow to a display of thesurgical instrument 2112, as is described in various U.S. PatentApplications that are incorporated by reference herein in the presentdisclosure. A diagnostic input or feedback entered by a non-sterileoperator at the visualization tower 21121 can be routed by the hub 2106to the surgical instrument display 2115 within the sterile field, whereit can be viewed by the operator of the surgical instrument 2112.Example surgical instruments that are suitable for use with the surgicalsystem 2102 are described in various U.S. Patent Applications that areincorporated by reference herein in the present disclosure.

FIG. 19 illustrates a computer-implemented interactive surgical system2200. The computer-implemented interactive surgical system 2200 issimilar in many respects to the computer-implemented interactivesurgical system 2100. The surgical system 2200 includes at least onesurgical hub 2236 in communication with a cloud 2204 that may include aremote server 2213. In one aspect, the computer-implemented interactivesurgical system 2200 comprises a surgical hub 2236 connected to multipleoperating theater devices such as, for example, intelligent surgicalinstruments, robots, and other computerized devices located in theoperating theater. The surgical hub 2236 comprises a communicationsinterface for communicably coupling the surgical hub 2236 to the cloud2204 and/or remote server 2213. As illustrated in the example of FIG.19, the surgical hub 2236 is coupled to an imaging module 2238 that iscoupled to an endoscope 2239, a generator module 2240 that is coupled toan energy device 2421, a smoke evacuator module 2226, asuction/irrigation module 2228, a communication module 2230, a processormodule 2232, a storage array 2234, a smart device/instrument 2235optionally coupled to a display 2237, and a non-contact sensor module2242. The operating theater devices are coupled to cloud computingresources and data storage via the surgical hub 2236. A robot hub 2222also may be connected to the surgical hub 2236 and to the cloudcomputing resources. The devices/instruments 2235, visualization systems2209, among others, may be coupled to the surgical hub 2236 via wired orwireless communication standards or protocols, as described herein. Thesurgical hub 2236 may be coupled to a hub display 2215 (e.g., monitor,screen) to display and overlay images received from the imaging module,device/instrument display, and/or other visualization systems 208. Thehub display also may display data received from devices connected to themodular control tower in conjunction with images and overlaid images.

Situational Awareness

The various visualization systems or aspects of visualization systemsdescribed herein can be utilized as part of a situational awarenesssystem that can be embodied or executed by a surgical hub 2106,2236(FIGS. 17-19). In particular, characterizing, identifying, and/orvisualizing surgical instruments or other surgical devices (includingtheir positions, orientations, and actions), tissues, structures, users,and other things located within the surgical field or the operatingtheater can provide contextual data that can be utilized by asituational awareness system to infer the type of surgical procedure ora step thereof being performed, the type of tissue(s) and/orstructure(s) being manipulated by the surgeon, and so on. Thiscontextual data can then be utilized by the situational awareness systemto provide alerts to users, suggest subsequent steps or actions for theusers to undertake, prepare surgical devices in anticipation for theiruse (e.g., activate an electrosurgical generator in anticipation of anelectrosurgical instrument being utilized in a subsequent step of thesurgical procedure), control surgical instruments intelligently (e.g.,customize surgical instrument operational parameters based on eachpatient's particular health profile), and so on.

Although an “intelligent” device including control algorithms thatrespond to sensed data can be an improvement over a “dumb” device thatoperates without accounting for sensed data, some sensed data can beincomplete or inconclusive when considered in isolation, i.e., withoutthe context of the type of surgical procedure being performed or thetype of tissue that is being operated on. Without knowing the proceduralcontext (e.g., knowing the type of tissue being operated on or the typeof procedure being performed), the control algorithm may control modulardevice incorrectly or suboptimally given the particular context-freesensed data. Modular devices can include any surgical devices that iscontrollable by a situational awareness system, such as visualizationsystem devices (e.g., a camera or display screen), surgical instruments(e.g., an ultrasonic surgical instrument, an electrosurgical instrument,or a surgical stapler), and other surgical devices (e.g., a smokeevacuator). For example, the optimal manner for a control algorithm tocontrol a surgical instrument in response to a particular sensedparameter can vary according to the particular tissue type beingoperated on. This is due to the fact that different tissue types havedifferent properties (e.g., resistance to tearing) and thus responddifferently to actions taken by surgical instruments. Therefore, it maybe desirable for a surgical instrument to take different actions evenwhen the same measurement for a particular parameter is sensed. As onespecific example, the optimal manner in which to control a surgicalstapling and cutting instrument in response to the instrument sensing anunexpectedly high force to close its end effector will vary dependingupon whether the tissue type is susceptible or resistant to tearing. Fortissues that are susceptible to tearing, such as lung tissue, theinstrument's control algorithm would optimally ramp down the motor inresponse to an unexpectedly high force to close to avoid tearing thetissue. For tissues that are resistant to tearing, such as stomachtissue, the instrument's control algorithm would optimally ramp up themotor in response to an unexpectedly high force to close to ensure thatthe end effector is clamped properly on the tissue. Without knowingwhether lung or stomach tissue has been clamped, the control algorithmmay make a suboptimal decision.

One solution utilizes a surgical hub including a system that isconfigured to derive information about the surgical procedure beingperformed based on data received from various data sources and thencontrol the paired modular devices accordingly. In other words, thesurgical hub is configured to infer information about the surgicalprocedure from received data and then control the modular devices pairedto the surgical hub based upon the inferred context of the surgicalprocedure. FIG. 20 illustrates a diagram of a situationally awaresurgical system 2400, in accordance with at least one aspect of thepresent disclosure. In some exemplifications, the data sources 2426include, for example, the modular devices 2402 (which can includesensors configured to detect parameters associated with the patientand/or the modular device itself), databases 2422 (e.g., an EMR databasecontaining patient records), and patient monitoring devices 2424 (e.g.,a blood pressure (BP) monitor and an electrocardiography (EKG) monitor).

A surgical hub 2404, which may be similar to the hub 106 in manyrespects, can be configured to derive the contextual informationpertaining to the surgical procedure from the data based upon, forexample, the particular combination(s) of received data or theparticular order in which the data is received from the data sources2426. The contextual information inferred from the received data caninclude, for example, the type of surgical procedure being performed,the particular step of the surgical procedure that the surgeon isperforming, the type of tissue being operated on, or the body cavitythat is the subject of the procedure. This ability by some aspects ofthe surgical hub 2404 to derive or infer information related to thesurgical procedure from received data can be referred to as “situationalawareness.” In one exemplification, the surgical hub 2404 canincorporate a situational awareness system, which is the hardware and/orprogramming associated with the surgical hub 2404 that derivescontextual information pertaining to the surgical procedure from thereceived data.

The situational awareness system of the surgical hub 2404 can beconfigured to derive the contextual information from the data receivedfrom the data sources 2426 in a variety of different ways. In oneexemplification, the situational awareness system includes a patternrecognition system, or machine learning system (e.g., an artificialneural network), that has been trained on training data to correlatevarious inputs (e.g., data from databases 2422, patient monitoringdevices 2424, and/or modular devices 2402) to corresponding contextualinformation regarding a surgical procedure. In other words, a machinelearning system can be trained to accurately derive contextualinformation regarding a surgical procedure from the provided inputs. Inanother exemplification, the situational awareness system can include alookup table storing pre-characterized contextual information regardinga surgical procedure in association with one or more inputs (or rangesof inputs) corresponding to the contextual information. In response to aquery with one or more inputs, the lookup table can return thecorresponding contextual information for the situational awarenesssystem for controlling the modular devices 2402. In one exemplification,the contextual information received by the situational awareness systemof the surgical hub 2404 is associated with a particular controladjustment or set of control adjustments for one or more modular devices2402. In another exemplification, the situational awareness systemincludes a further machine learning system, lookup table, or other suchsystem, which generates or retrieves one or more control adjustments forone or more modular devices 2402 when provided the contextualinformation as input.

A surgical hub 2404 incorporating a situational awareness systemprovides a number of benefits for the surgical system 2400. One benefitincludes improving the interpretation of sensed and collected data,which would in turn improve the processing accuracy and/or the usage ofthe data during the course of a surgical procedure. To return to aprevious example, a situationally aware surgical hub 2404 coulddetermine what type of tissue was being operated on; therefore, when anunexpectedly high force to close the surgical instrument's end effectoris detected, the situationally aware surgical hub 2404 could correctlyramp up or ramp down the motor of the surgical instrument for the typeof tissue.

As another example, the type of tissue being operated can affect theadjustments that are made to the compression rate and load thresholds ofa surgical stapling and cutting instrument for a particular tissue gapmeasurement. A situationally aware surgical hub 2404 could infer whethera surgical procedure being performed is a thoracic or an abdominalprocedure, allowing the surgical hub 2404 to determine whether thetissue clamped by an end effector of the surgical stapling and cuttinginstrument is lung (for a thoracic procedure) or stomach (for anabdominal procedure) tissue. The surgical hub 2404 could then adjust thecompression rate and load thresholds of the surgical stapling andcutting instrument appropriately for the type of tissue.

As yet another example, the type of body cavity being operated in duringan insufflation procedure can affect the function of a smoke evacuator.A situationally aware surgical hub 2404 could determine whether thesurgical site is under pressure (by determining that the surgicalprocedure is utilizing insufflation) and determine the procedure type.As a procedure type is generally performed in a specific body cavity,the surgical hub 2404 could then control the motor rate of the smokeevacuator appropriately for the body cavity being operated in. Thus, asituationally aware surgical hub 2404 could provide a consistent amountof smoke evacuation for both thoracic and abdominal procedures.

As yet another example, the type of procedure being performed can affectthe optimal energy level for an ultrasonic surgical instrument or radiofrequency (RF) electrosurgical instrument to operate at. Arthroscopicprocedures, for example, require higher energy levels because the endeffector of the ultrasonic surgical instrument or RF electrosurgicalinstrument is immersed in fluid. A situationally aware surgical hub 2404could determine whether the surgical procedure is an arthroscopicprocedure. The surgical hub 2404 could then adjust the RF power level orthe ultrasonic amplitude of the generator (i.e., “energy level”) tocompensate for the fluid filled environment. Relatedly, the type oftissue being operated on can affect the optimal energy level for anultrasonic surgical instrument or RF electrosurgical instrument tooperate at. A situationally aware surgical hub 2404 could determine whattype of surgical procedure is being performed and then customize theenergy level for the ultrasonic surgical instrument or RFelectrosurgical instrument, respectively, according to the expectedtissue profile for the surgical procedure. Furthermore, a situationallyaware surgical hub 2404 can be configured to adjust the energy level forthe ultrasonic surgical instrument or RF electrosurgical instrumentthroughout the course of a surgical procedure, rather than just on aprocedure-by-procedure basis. A situationally aware surgical hub 2404could determine what step of the surgical procedure is being performedor will subsequently be performed and then update the control algorithmsfor the generator and/or ultrasonic surgical instrument or RFelectrosurgical instrument to set the energy level at a valueappropriate for the expected tissue type according to the surgicalprocedure step.

As yet another example, data can be drawn from additional data sources2426 to improve the conclusions that the surgical hub 2404 draws fromone data source 2426. A situationally aware surgical hub 2404 couldaugment data that it receives from the modular devices 2402 withcontextual information that it has built up regarding the surgicalprocedure from other data sources 2426. For example, a situationallyaware surgical hub 2404 can be configured to determine whetherhemostasis has occurred (i.e., whether bleeding at a surgical site hasstopped) according to video or image data received from a medicalimaging device. However, in some cases the video or image data can beinconclusive. Therefore, in one exemplification, the surgical hub 2404can be further configured to compare a physiologic measurement (e.g.,blood pressure sensed by a BP monitor communicably connected to thesurgical hub 2404) with the visual or image data of hemostasis (e.g.,from a medical imaging device 124 (FIG. 2) communicably coupled to thesurgical hub 2404) to make a determination on the integrity of thestaple line or tissue weld. In other words, the situational awarenesssystem of the surgical hub 2404 can consider the physiologicalmeasurement data to provide additional context in analyzing thevisualization data. The additional context can be useful when thevisualization data may be inconclusive or incomplete on its own.

Another benefit includes proactively and automatically controlling thepaired modular devices 2402 according to the particular step of thesurgical procedure that is being performed to reduce the number of timesthat medical personnel are required to interact with or control thesurgical system 2400 during the course of a surgical procedure. Forexample, a situationally aware surgical hub 2404 could proactivelyactivate the generator to which an RF electrosurgical instrument isconnected if it determines that a subsequent step of the procedurerequires the use of the instrument. Proactively activating the energysource allows the instrument to be ready for use a soon as the precedingstep of the procedure is completed.

As another example, a situationally aware surgical hub 2404 coulddetermine whether the current or subsequent step of the surgicalprocedure requires a different view or degree of magnification on thedisplay according to the feature(s) at the surgical site that thesurgeon is expected to need to view. The surgical hub 2404 could thenproactively change the displayed view (supplied by, e.g., a medicalimaging device for the visualization system 108) accordingly so that thedisplay automatically adjusts throughout the surgical procedure.

As yet another example, a situationally aware surgical hub 2404 coulddetermine which step of the surgical procedure is being performed orwill subsequently be performed and whether particular data orcomparisons between data will be required for that step of the surgicalprocedure. The surgical hub 2404 can be configured to automatically callup data screens based upon the step of the surgical procedure beingperformed, without waiting for the surgeon to ask for the particularinformation.

Another benefit includes checking for errors during the setup of thesurgical procedure or during the course of the surgical procedure. Forexample, a situationally aware surgical hub 2404 could determine whetherthe operating theater is setup properly or optimally for the surgicalprocedure to be performed. The surgical hub 2404 can be configured todetermine the type of surgical procedure being performed, retrieve thecorresponding checklists, product location, or setup needs (e.g., from amemory), and then compare the current operating theater layout to thestandard layout for the type of surgical procedure that the surgical hub2404 determines is being performed. In one exemplification, the surgicalhub 2404 can be configured to compare the list of items for theprocedure scanned by a suitable scanner for example and/or a list ofdevices paired with the surgical hub 2404 to a recommended oranticipated manifest of items and/or devices for the given surgicalprocedure. If there are any discontinuities between the lists, thesurgical hub 2404 can be configured to provide an alert indicating thata particular modular device 2402, patient monitoring device 2424, and/orother surgical item is missing. In one exemplification, the surgical hub2404 can be configured to determine the relative distance or position ofthe modular devices 2402 and patient monitoring devices 2424 viaproximity sensors, for example. The surgical hub 2404 can compare therelative positions of the devices to a recommended or anticipated layoutfor the particular surgical procedure. If there are any discontinuitiesbetween the layouts, the surgical hub 2404 can be configured to providean alert indicating that the current layout for the surgical proceduredeviates from the recommended layout.

As another example, a situationally aware surgical hub 2404 coulddetermine whether the surgeon (or other medical personnel) was making anerror or otherwise deviating from the expected course of action duringthe course of a surgical procedure. For example, the surgical hub 2404can be configured to determine the type of surgical procedure beingperformed, retrieve the corresponding list of steps or order ofequipment usage (e.g., from a memory), and then compare the steps beingperformed or the equipment being used during the course of the surgicalprocedure to the expected steps or equipment for the type of surgicalprocedure that the surgical hub 2404 determined is being performed. Inone exemplification, the surgical hub 2404 can be configured to providean alert indicating that an unexpected action is being performed or anunexpected device is being utilized at the particular step in thesurgical procedure.

Overall, the situational awareness system for the surgical hub 2404improves surgical procedure outcomes by adjusting the surgicalinstruments (and other modular devices 2402) for the particular contextof each surgical procedure (such as adjusting to different tissue types)and validating actions during a surgical procedure. The situationalawareness system also improves surgeons' efficiency in performingsurgical procedures by automatically suggesting next steps, providingdata, and adjusting displays and other modular devices 2402 in thesurgical theater according to the specific context of the procedure.

Referring now to FIG. 21, a timeline 2500 depicting situationalawareness of a hub, such as the surgical hub 106 or 206 (FIGS. 1-11),for example, is depicted. The timeline 2500 is an illustrative surgicalprocedure and the contextual information that the surgical hub 106, 206can derive from the data received from the data sources at each step inthe surgical procedure. The timeline 2500 depicts the typical steps thatwould be taken by the nurses, surgeons, and other medical personnelduring the course of a lung segmentectomy procedure, beginning withsetting up the operating theater and ending with transferring thepatient to a post-operative recovery room.

The situationally aware surgical hub 106, 206 receives data from thedata sources throughout the course of the surgical procedure, includingdata generated each time medical personnel utilize a modular device thatis paired with the surgical hub 106, 206. The surgical hub 106, 206 canreceive this data from the paired modular devices and other data sourcesand continually derive inferences (i.e., contextual information) aboutthe ongoing procedure as new data is received, such as which step of theprocedure is being performed at any given time. The situationalawareness system of the surgical hub 106, 206 is able to, for example,record data pertaining to the procedure for generating reports, verifythe steps being taken by the medical personnel, provide data or prompts(e.g., via a display screen) that may be pertinent for the particularprocedural step, adjust modular devices based on the context (e.g.,activate monitors, adjust the field of view (FOV) of the medical imagingdevice, or change the energy level of an ultrasonic surgical instrumentor RF electrosurgical instrument), and take any other such actiondescribed above.

As the first step 2502 in this illustrative procedure, the hospitalstaff members retrieve the patient's EMR from the hospital's EMRdatabase. Based on select patient data in the EMR, the surgical hub 106,206 determines that the procedure to be performed is a thoracicprocedure.

Second step 2504, the staff members scan the incoming medical suppliesfor the procedure. The surgical hub 106, 206 cross-references thescanned supplies with a list of supplies that are utilized in varioustypes of procedures and confirms that the mix of supplies corresponds toa thoracic procedure. Further, the surgical hub 106, 206 is also able todetermine that the procedure is not a wedge procedure (because theincoming supplies either lack certain supplies that are necessary for athoracic wedge procedure or do not otherwise correspond to a thoracicwedge procedure).

Third step 2506, the medical personnel scan the patient band via ascanner that is communicably connected to the surgical hub 106, 206. Thesurgical hub 106, 206 can then confirm the patient's identity based onthe scanned data.

Fourth step 2508, the medical staff turns on the auxiliary equipment.The auxiliary equipment being utilized can vary according to the type ofsurgical procedure and the techniques to be used by the surgeon, but inthis illustrative case they include a smoke evacuator, insufflator, andmedical imaging device. When activated, the auxiliary equipment that aremodular devices can automatically pair with the surgical hub 106, 206that is located within a particular vicinity of the modular devices aspart of their initialization process. The surgical hub 106, 206 can thenderive contextual information about the surgical procedure by detectingthe types of modular devices that pair with it during this pre-operativeor initialization phase. In this particular example, the surgical hub106, 206 determines that the surgical procedure is a VATS procedurebased on this particular combination of paired modular devices. Based onthe combination of the data from the patient's EMR, the list of medicalsupplies to be used in the procedure, and the type of modular devicesthat connect to the hub, the surgical hub 106, 206 can generally inferthe specific procedure that the surgical team will be performing. Oncethe surgical hub 106, 206 knows what specific procedure is beingperformed, the surgical hub 106, 206 can then retrieve the steps of thatprocedure from a memory or from the cloud and then cross-reference thedata it subsequently receives from the connected data sources (e.g.,modular devices and patient monitoring devices) to infer what step ofthe surgical procedure the surgical team is performing.

Fifth step 2510, the staff members attach the EKG electrodes and otherpatient monitoring devices to the patient. The EKG electrodes and otherpatient monitoring devices are able to pair with the surgical hub 106,206. As the surgical hub 106, 206 begins receiving data from the patientmonitoring devices, the surgical hub 106, 206 thus confirms that thepatient is in the operating theater.

Sixth step 2512, the medical personnel induce anesthesia in the patient.The surgical hub 106, 206 can infer that the patient is under anesthesiabased on data from the modular devices and/or patient monitoringdevices, including EKG data, blood pressure data, ventilator data, orcombinations thereof, for example. Upon completion of the sixth step2512, the pre-operative portion of the lung segmentectomy procedure iscompleted and the operative portion begins.

Seventh step 2514, the patient's lung that is being operated on iscollapsed (while ventilation is switched to the contralateral lung). Thesurgical hub 106, 206 can infer from the ventilator data that thepatient's lung has been collapsed, for example. The surgical hub 106,206 can infer that the operative portion of the procedure has commencedas it can compare the detection of the patient's lung collapsing to theexpected steps of the procedure (which can be accessed or retrievedpreviously) and thereby determine that collapsing the lung is the firstoperative step in this particular procedure.

Eighth step 2516, the medical imaging device (e.g., a scope) is insertedand video from the medical imaging device is initiated. The surgical hub106, 206 receives the medical imaging device data (i.e., video or imagedata) through its connection to the medical imaging device. Upon receiptof the medical imaging device data, the surgical hub 106, 206 candetermine that the laparoscopic portion of the surgical procedure hascommenced. Further, the surgical hub 106, 206 can determine that theparticular procedure being performed is a segmentectomy, as opposed to alobectomy (note that a wedge procedure has already been discounted bythe surgical hub 106, 206 based on data received at the second step 2504of the procedure). The data from the medical imaging device 124 (FIG. 2)can be utilized to determine contextual information regarding the typeof procedure being performed in a number of different ways, including bydetermining the angle at which the medical imaging device is orientedwith respect to the visualization of the patient's anatomy, monitoringthe number or medical imaging devices being utilized (i.e., that areactivated and paired with the surgical hub 106, 206), and monitoring thetypes of visualization devices utilized. For example, one technique forperforming a VATS lobectomy places the camera in the lower anteriorcorner of the patient's chest cavity above the diaphragm, whereas onetechnique for performing a VATS segmentectomy places the camera in ananterior intercostal position relative to the segmental fissure. Usingpattern recognition or machine learning techniques, for example, thesituational awareness system can be trained to recognize the positioningof the medical imaging device according to the visualization of thepatient's anatomy. As another example, one technique for performing aVATS lobectomy utilizes a single medical imaging device, whereas anothertechnique for performing a VATS segmentectomy utilizes multiple cameras.As yet another example, one technique for performing a VATSsegmentectomy utilizes an infrared light source (which can becommunicably coupled to the surgical hub as part of the visualizationsystem) to visualize the segmental fissure, which is not utilized in aVATS lobectomy. By tracking any or all of this data from the medicalimaging device, the surgical hub 106, 206 can thereby determine thespecific type of surgical procedure being performed and/or the techniquebeing used for a particular type of surgical procedure.

Ninth step 2518, the surgical team begins the dissection step of theprocedure. The surgical hub 106, 206 can infer that the surgeon is inthe process of dissecting to mobilize the patient's lung because itreceives data from the RF or ultrasonic generator indicating that anenergy instrument is being fired. The surgical hub 106, 206 cancross-reference the received data with the retrieved steps of thesurgical procedure to determine that an energy instrument being fired atthis point in the process (i.e., after the completion of the previouslydiscussed steps of the procedure) corresponds to the dissection step. Incertain instances, the energy instrument can be an energy tool mountedto a robotic arm of a robotic surgical system.

Tenth step 2520, the surgical team proceeds to the ligation step of theprocedure. The surgical hub 106, 206 can infer that the surgeon isligating arteries and veins because it receives data from the surgicalstapling and cutting instrument indicating that the instrument is beingfired. Similarly to the prior step, the surgical hub 106, 206 can derivethis inference by cross-referencing the receipt of data from thesurgical stapling and cutting instrument with the retrieved steps in theprocess. In certain instances, the surgical instrument can be a surgicaltool mounted to a robotic arm of a robotic surgical system.

Eleventh step 2522, the segmentectomy portion of the procedure isperformed. The surgical hub 106, 206 can infer that the surgeon istransecting the parenchyma based on data from the surgical stapling andcutting instrument, including data from its cartridge. The cartridgedata can correspond to the size or type of staple being fired by theinstrument, for example. As different types of staples are utilized fordifferent types of tissues, the cartridge data can thus indicate thetype of tissue being stapled and/or transected. In this case, the typeof staple being fired is utilized for parenchyma (or other similartissue types), which allows the surgical hub 106, 206 to infer that thesegmentectomy portion of the procedure is being performed.

Twelfth step 2524, the node dissection step is then performed. Thesurgical hub 106, 206 can infer that the surgical team is dissecting thenode and performing a leak test based on data received from thegenerator indicating that an RF or ultrasonic instrument is being fired.For this particular procedure, an RF or ultrasonic instrument beingutilized after parenchyma was transected corresponds to the nodedissection step, which allows the surgical hub 106, 206 to make thisinference. It should be noted that surgeons regularly switch back andforth between surgical stapling/cutting instruments and surgical energy(i.e., RF or ultrasonic) instruments depending upon the particular stepin the procedure because different instruments are better adapted forparticular tasks. Therefore, the particular sequence in which thestapling/cutting instruments and surgical energy instruments are usedcan indicate what step of the procedure the surgeon is performing.Moreover, in certain instances, robotic tools can be utilized for one ormore steps in a surgical procedure and/or handheld surgical instrumentscan be utilized for one or more steps in the surgical procedure. Thesurgeon(s) can alternate between robotic tools and handheld surgicalinstruments and/or can use the devices concurrently, for example. Uponcompletion of the twelfth step 2524, the incisions are closed up and thepost-operative portion of the procedure begins.

Thirteenth step 2526, the patient's anesthesia is reversed. The surgicalhub 106, 206 can infer that the patient is emerging from the anesthesiabased on the ventilator data (i.e., the patient's breathing rate beginsincreasing), for example.

Lastly, the fourteenth step 2528 is that the medical personnel removethe various patient monitoring devices from the patient. The surgicalhub 2106, 2236 can thus infer that the patient is being transferred to arecovery room when the hub loses EKG, BP, and other data from thepatient monitoring devices. As can be seen from the description of thisillustrative procedure, the surgical hub 2106, 2236 can determine orinfer when each step of a given surgical procedure is taking placeaccording to data received from the various data sources that arecommunicably coupled to the surgical hub 2106, 2236.

Situational awareness is further described in various U.S. PatentApplications that are incorporated by reference herein in the presentdisclosure, which is herein incorporated by reference in its entirety.In certain instances, operation of a robotic surgical system, includingthe various robotic surgical systems disclosed herein, for example, canbe controlled by the hub 2106, 2236 based on its situational awarenessand/or feedback from the components thereof and/or based on informationfrom the cloud 2104 (FIG. 17).

Analyzing Surgical Procedure Trends and Surgical Actions

One issue inherent to surgical procedures is that they are performed byindividuals who may utilize different techniques in performing any givensurgical procedure. In some cases, the surgical outcome associated withany given decision point in a surgical procedure can be direct and easyto identify. For example, the amount of bleeding that occurs aftermaking an incision is direct and easy to identify because one cangenerally visualize the blood, and it is highly time correlated with theact of making the incision. However, oftentimes the surgical outcomeassociated a surgical procedure decision point can be highly attenuatedfrom the decision itself. For example, there can be a large time delay(e.g., years) in the readmission of patients who underwent surgicalprocedures performed by a given surgeon, and it is unlikely that itcould be determined which particular action taken by the surgeon led tothe readmission. This dynamic can create a substantial disconnectbetween identifying and correcting surgical techniques that are notideal or are otherwise not associated with the most positive surgicaloutcomes. However, surgical systems can be configured to trackperioperative surgical data, such as via surgical hubs 2106, 2236 asdescribed above under the heading SURGICAL HUB SYSTEM, for analysis bycomputer systems (e.g., the cloud 2204 and/or remove servers 2213).Further, surgical systems can be configured to determine contextualinformation associated with surgical procedures, as described aboveunder the heading SITUATIONAL AWARENESS. The ability to trackperioperative surgical data, determine contextual information associatedwith the surgical procedures, and analyze all of this data across anetwork of surgical systems spread across a region or even the world canbe leveraged to identify and track trends associated with the variousdecision points associated with a surgical procedure (e.g., what typesof surgical devices to use in the procedure, where to make an incision,or how much tissue to remove) and then determine which actions are mosthighly correlated to surgical outcomes (e.g., the amount of bleeding atan incision, whether any intraoperative corrective actions werenecessary, reoperation rates, postoperative bleeding rates, orreadmission rates) that are positive in order to suggest particularactions at the various decisions points associated with a surgicalprocedure.

In various aspects, a surgical system can be configured to monitor theactions taken by users in performing a surgical procedure and thenprovide recommendations or alerts when the actions deviate from thebaseline actions. The baseline actions can be determined by monitoringor recording the performance of surgical procedures, determining thesurgical outcomes associated with the various surgical procedures,determining which particular surgical actions are most associated withpositive surgical outcomes, and then establishing baselines for thevarious surgical actions in each surgical procedure type according towhich actions are associated with positive surgical outcomes. Forexample, FIG. 22 is a diagram of a surgical system 7000 that could beconfigured to implement the aforementioned techniques. The surgicalsystem 7000 includes a control system 7002 that is coupled to an imagingsystem 7004 and a back-end computer system 7010 via a data network(e.g., a LAN, a WAN, or the Internet). In one aspect, the control system7002 can include the control system 133 described in connection withFIG. 2, a surgical hub 2106,2236 as described in connection with FIGS.17-19, and other such systems. The control system 7002 can include theimaging system 142 (FIG. 2) or any other such imaging or visualizationsystems described in connection with FIGS. 1-19, including imagingsystems that are configured to utilize structure electromagneticradiation (EMR) techniques and/or multispectral imaging techniques tocharacterize objects. The back-end computer system 7010 can include acloud computing architecture or another computer system configured tostore and execute various machine learning models or other algorithms.

At least in part by visualizing what is occurring in a surgicalprocedure via the imaging system 7004, the surgical system 7000 canmonitor decision points within the procedure (e.g., device selection,stapler cartridge selection, or order of operating steps) and log thesedecisions. The surgical system 7000 can utilize the imaging system 7004to monitor intraoperative decision points by visualizing objects thatenter the field of view (FOV) of the imaging system 7004 and thenperforming (e.g., by the control system 7002) object recognition orother computer vision techniques to identify the surgical devices beingutilized in the surgical procedure, the particular organ or tissue beingoperated on, and so on. The identified actions taken by the surgeon atthe various decision points can then be utilized to inform algorithmsthat balance patient factors, surgeon factors, device utilization, andclinical outcome data to, for example, train machine learning models(e.g., an artificial neural network) using supervised or unsupervisedmachine learning techniques. Once trained, the machine learning modelscan offer suggestions to users when a statistically significant outcomecould be influenced by a decision point during the surgical procedure.Further, these machine learning models or other algorithms could beutilized to postoperatively review actions taken by the surgical staffduring a surgical procedure and flag actions for review by the surgicalstaff. The surgical staff could then be provided the opportunity toconfirm or disagree with each flagged assessment to better inform andtrain both the surgical staff and the algorithm. In one aspect, thecontrol system 7002 can be configured to collect perioperative data andthen provide (e.g., intraoperatively or postoperatively) the data to aback-end computer system 7010 (e.g., a cloud computing system) via thedata network 7008. The back-end computer system 7010 can then beconfigured to execute and train the machine learning models or otheralgorithms based on the data provided by the control system 7002 ornetwork of control systems 7002 to which it is connected. In one aspect,the trained machine learning models can be executed by the back-endcomputer system 7010 and provide recommendations or analysis to thecontrol system 7002 in real time, during the performance of a surgicalprocedure, based on intraoperative data provided by the control system7002. In one aspect, the trained machine learning models can be providedto and executed by the control systems 7002 themselves.

In one aspect, the surgical system 7000 can be configured to analyze thevarious actions being taken during the surgical procedure, such as thetype of surgical instrument selected to perform a given surgicalprocedure step or the position or orientation of the surgical instrumentrelative to the patient's tissues, via an imaging system 7004 thatincludes a structured light system (e.g., a structured light source 152)to identify objects within the FOV of the imaging system 7004 andthereby enable adaptive responses and comparisons between currentactions with previous actions in similar surgical procedure types. Inparticular, the surgical system 7000 can be configured to compileperioperative data from multiple data sources to provide trends andreferences for structured light tracking of objects during a surgicalprocedure. The visualized surgical procedure data can be compared withclinical outcomes resulting during the performance of the procedure orafter the procedure to determine trends in the techniques utilized forparticular surgical procedure steps, the types of surgical instrumentsutilized, and other decision points with the clinical outcomes toprovide future baselines. These baselines could thus define the bestpractices for performing a given surgical procedure.

In one implementation, the control system 7002 can be configured toexecute various control algorithms, as described in connection with FIG.2, including surface mapping logic 136, imaging logic 138, tissueidentification logic 140, distance determining logic 141, targetinglogic, and/or trajectory projecting logic. The control algorithms can beconfigured to control surgical instruments or other components of thesurgical system 7000, display information to users, and/or control arobotic system 2110 (FIG. 17). The machine learning models or algorithmsbeing trained on the perioperative surgical action data and the surgicaloutcome data can further be utilized to refine the various controlalgorithms executed by the control system 7002. In particular, targetingor trajectory projecting logic could be refined based on thevisualization of tissue volumes and surfaces (e.g., as determined by astructured light system of the imaging system 7004) in combination withlocally measured surgical instrument parameters. This intraoperativedata can then be utilized in conjunction with the surgical outcome data,which could include data associated with interactions between the tissueand the surgical instrument, to improve control algorithms of thedevices.

In another implementation, the control system 7002 can be configured torecord the positions of the surgical devices utilized in a surgicalprocedure relative to the patient in a local or global coordinatesystem. A local coordinate system could be defined relative to, forexample, the surgical devices themselves, particular tissues or organs,or virtual points of view, as described in U.S. patent application Ser.No. 16/729,803, titled ADAPTIVE VISUALIZATION BY A SURGICAL SYSTEM,filed on Dec. 30, 2019, which is hereby incorporated by reference hereinin its entirety. A global coordinate system could be defined relativeto, for example, the patient or the operating theater. In combinationwith the recordation of the surgical devices' positions, the controlsystem 7002 can be configured to record the functions performed by thesurgical devices, such as whether a surgical instrument was fired, thepower level of the surgical instrument, or tissue characteristics orother parameters sensed by the surgical instrument. Accordingly, thesurgical devices' positions and functions can be utilized toinform/train the machine learning models or other algorithms, which canthen correlate the relative positions and functions of the surgicaldevices to positive surgical outcomes to help surgeons improve techniqueor provide more precise information to study and improve surgical devicefunctions. For example, an algorithm could be developed to change thefunction of the articulation buttons of a surgical instrument based ondata that changing the function of the articulation buttons results inbetter surgical outcomes, possibly due to the articulation buttons beingunintuitive when the surgical instrument is in a particular positionand/or performing a particular function.

In another implementation, the control system 7002 can be configured tocontinuously monitor the movements of the surgeon in search of wastedsteps, unnecessary tissue contact/manipulation, or actions/steps thatwere unexpected based on situational awareness. The control system 7002could flag such identified events for postoperative review by thesurgeon and provide the surgeon with the opportunity to confirm ordisagree with each flagged assessment to better inform/train both thesurgeon and the algorithm.

One example of an algorithm that can be utilized to perform the varioustechniques or implementations described above is shown in FIG. 23, whichis a logic flow diagram of a process 7100 for providing dynamic surgicalrecommendations to users. In the following description of the process7100, reference should also be made to FIG. 2, FIGS. 17-19, and FIG. 22.The process 7100 can be embodied as, for example, instructions stored ina memory 134 coupled to a control circuit 132 that, when executed by thecontrol circuit 132, cause the control circuit 132 to perform theenumerated steps of the process 7100. It should be understood that theprocess 7100 can be executed by and/or between the control system 7002(which can include a surgical hub 2106, 2236) and the back-end computersystem 7010 (which can include the cloud 2204 or remote server 2213).Accordingly, the control circuit 132 can collectively refer to one ormultiple control circuits associated with or distributed between thecontrol system 7002 and the back-end computer system 7010. In otherwords, the control circuit 132 could include a control circuit of thecontrol system 7002 and/or a control circuit of the back-end computersystem 7010. For brevity, the process 7100 is described as beingexecuted by the control system 7002 and the back-end computer system7010; however, it should be understood that the process 7100 can beexecuted by other combinations of hardware, software, and/or firmwareand that any particular step of the process 7100 can be executed byeither the control system 7002 or the back-end computer system 7010.

Accordingly, the control system 7002 and/or the back-end computer system7010 executing the process 7100 can receive 7102 images (e.g., capturedvia the imaging system 7004) of a surgical procedure being performed andperioperative data. The images can be associated with perioperativedata, such as positions of surgical devices in local or globalcoordinate systems, sensor measurements, object recognition data, and soon. Further, the images can be generated at least in part based on astructured light system and can thus include three-dimensional (3D)volumetric data or surface mapping data. In one implementation, thecontrol system 7002 can initially generate the images via the imagingsystem 7004 and then provide the image data to the back-end computersystem 7010 for processing thereby. The back-end computer system 7010can be communicatively connected to a number of different controlsystems 7002, which can in turn be located in or associated with anumber of different facilities or hospital networks. Thus, the back-endcomputer system 7010 can receive the surgical image data across a numberof different control systems 7002 to train the machine learning modelsor other algorithms.

Accordingly, the control system 7002 and/or the back-end computer system7010 can determine 7104 surgical outcomes associated with the surgicalprocedures for which the perioperative data was received. In one aspect,the control system 7002 could determine a surgical outcome by, forexample, visualizing the surgical outcome (e.g., bleeding along anincision line) via the imaging system 7004. In another aspect, theback-end computer system 7010 could determine a surgical outcome by, forexample, storing a database of surgical outcomes associated with a givensurgical procedure. The database could be updated as additionalinformation related to the patient is received by the back-end computersystem 7010, or the back-end computer system 7010 could allow users toupdate the database as surgical outcomes are identified. For example,users (e.g., medical facility personnel) could update the database whena patient returns for a reoperation procedure or reports undue amountsof pain or other negative outcomes associated with the surgicalprocedure.

Accordingly, the control system 7002 and/or the back-end computer system7010 can determine 7106 a baseline surgical action corresponding to theimages and the outcome data. In one aspect, the back-end computer system7010 can be programmed to execute and train a machine learning model tocorrelate the received images and other perioperative data with thedetermined outcomes to establish the surgical action at each defineddecision point in the surgical procedure that is most correlated (orcorrelated at least above a threshold) to desired or positive surgicaloutcomes. Such surgical actions can thus be defined as the baseline orrecommended surgical actions to be performed at each decision pointassociated with each surgical procedure type. Once trained, the machinelearning model can then be utilized to provide preoperative,intraoperative, or postoperative recommendations to users according tothe defined baseline.

Accordingly, the control system 7002 can generate 7108 an image of thesurgical site during a surgical procedure via, for example, the imagingsystem 7004. The image can be generated 7108 using structured EMR,multispectral imaging, or any other imaging techniques described above.Further, the image can be associated with a variety of perioperativedata, including, for example, surface mapping or 3D geometry determinedvia structured EMR, subsurface or tissue characteristic data determinedvia multispectral imaging techniques, object recognition data,positional data relative to global and/or local coordinates systems,and/or contextual data determined via a situational awareness system.

Accordingly, the control system 7002 and/or back-end computer system7010 can determine 7110 a surgical action that is being performed at agiven decision point in the surgical procedure. In one aspect, thecontrol system 7002 and/or back-end computer system 7010 can make thisdetermination via a situational awareness system. For example, thecontrol system 7002 could determine that the surgeon is dissecting tomobilize a lung, ligating vessels, or transecting parenchyma based upongenerator data and surgical instrument data (including the relativeactivations of the surgical devices), as described above in connectionwith FIG. 21. In this example, the decision points for the surgicalactions would include what devices are being utilized for the particularstep of the surgical procedure (e.g., ultrasonic instrument orelectrosurgical instrument, size and type of staple cartridge, or brandof surgical instrument), where or what the surgeon is transecting orligating, and so on. As another example, the control system 7002 and/orback-end computer system 7010 could determine what preoperative mix ofsurgical devices are planned for the surgical procedure by visualizingthe prep table in the operating theater. In this example, the decisionpoint for the surgical action would thus be the selected surgicaldevices for the procedure.

Accordingly, the control system 7002 and/or back-end computer system7010 can compare 7112 the current surgical action to the baselinesurgical action for the given decision point of the surgical procedurethat was determined using the techniques described above. Accordingly,the control system 7002 and/or back-end computer system 7010 can provide7114 a recommendation based on the comparison between the surgicalaction and the baseline. In various aspects, the recommendation can beprovided preoperatively (e.g., recommending a different mix of surgicaldevices to perform the procedure), intraoperatively (e.g., recommendinga different position for the end effector of the surgical instrument),or postoperatively (e.g., recommending different surgical actions atflagged points in the procedure via a report to be reviewed by thesurgeon). In one aspect, the recommendation can only be provided if thesurgical action deviates from the baseline by at least a thresholdamount. The recommendation can take the form of an audible alert,textual or graphical feedback, haptic feedback, and so on. As oneexample shown in FIG. 24, a display 7006 coupled to the control system7002 can display a video feed 7200 of the surgical site 7014 as providedby the imaging system 7004. The video feed 7200 can show the position ofthe surgical instrument 7210 and visualizations of other tissues and/orstructures, which in this specific example include a tumor 7016 andvarious vessels 7018. In this example, the control system 7002 and/orback-end computer system 7010 has determined that the position of thesurgical instrument 7210 has deviated from the baseline position for thegiven step of the surgical procedure. Accordingly, the control system7002 has caused the display 7006 to provide 7114 a recommendation in theform of a graphical overlay 7212 that shows the recommended or baselineposition for the surgical instrument 7210 for the given surgicalprocedure step.

These systems and methods allow surgeons to visualize what therecommended course of action for any given decision point in thesurgical procedure would be and then act accordingly. Surgeons couldtherefore learn and further develop based on feedback derived from largeamounts of data collected from any number of surgical proceduresperformed by any number of individuals throughout the world. This wouldallow surgeons to further hone their intraoperative techniques or otherdecisions associated with the performance of surgical procedures toimprove patient outcomes. Further, such systems could be integrated intorobotic surgical systems to leverage the vast amount of availablesurgical data to improve their control algorithms and thereby controlthe performance of the robotic surgical systems over time.

In one aspect, surgical systems could also be configured to predict andproject an effect of an action that could be taken during a surgicalprocedure for users. In particular, 3D surface and volume visualizationsof tissues and/or structures could be combined with a computationalanalysis and modeling data set derived from a data source to record theeffects of various surgical devices on the tissues and/or structures.For example, a surgical system 7000 could, via an imaging system 7004,visualize the surgical site 7014 (including any tissues and/orstructures located there) and then record the effects on the varioustissues and/or structures in response to various treatments, such asfiring a surgical stapler or firing an electrosurgical instrument. Theeffects on the tissues and/or structures could then be recorded andmodeled for any given type(s), size(s), and configuration(s) of thetissues and/or structures. Further, a computational analysis could thenbe executed (e.g., by the control system 7002) to predict an aspect ofthe treatment projection from the surgical device being utilized in thesurgical procedure. For example, a treatment projection could includethe application of thermal or electrical energy to a tissue and theextent to which the application of energy would penetrate into the 3Dscanned volume of the tissue. This treatment projection could beprovided to the user as a graphical overlay on the video feed 7200 shownon the display 7006, for example.

In one aspect, the projection from the model could be determinedseparately from and compared against predictions developed by othermodels or surgical devices. For example, the imaging system 7004 couldinclude a secondary sensing array (e.g., an IR CMOS array) configured tosense tissues characteristics and project the application of energy tothe tissue to compare the projections with projections forecast fromother models or surgical devices (e.g., an electrosurgical generator).Further, the forecast from the other data source could be adjusted basedon the comparative accuracy of the projection modeled by the controlsystem 7002 relative to the forecast from the other data source, asdetermined according to historical surgical procedure data. For example,a power level of an electrosurgical instrument or ultrasonic surgicalinstrument and the visualization of the tissue-to-instrument jawinteraction could be utilized to provide the algorithm (which could bebased on finite element analysis, for example) and the boundaryconditions of the forecast (e.g., by the generator).

In one aspect, when the prediction from the computational analysis ofthe imaging system 7004 and the prediction from the algorithm executedby the other data (e.g., surgical generator) differ by at least athreshold, the control system 7002 could take a variety of differentactions. For example, the control system 7002 could provide a user alert(e.g., emit a different tone than normal) prior to the user opening thejaws to inspect the tissue, notify the user after completion of thesurgical step (e.g., emit a different tone at the end of the energydelivery by the surgical instrument), soft lockout the jaws of thesurgical instrument (e.g., until overridden by the user), or adjust thegenerator control algorithm to adjust the delivery of energy to thetissue (e.g., extend the delivery of energy to ensure a safe outcome atthe cost of additional time).

These systems and methods allow surgeons to visualize what a predictedcourse of action for any given decision point in the surgical procedurewould be and then act accordingly. Surgeons could therefore make moreinformed intraoperative decisions based on feedback derived from largeamounts of data collected from any number of surgical proceduresperformed by any number of individuals throughout the world. This wouldallow surgeons to further hone their intraoperative techniques toimprove patient outcomes. Further, such systems could be integrated intorobotic surgical systems to leverage the vast amount of availablesurgical data to improve their control algorithms and thereby controlthe performance of the robotic surgical systems over time.

Example Clinical Applications

Various surgical visualization systems disclosed herein may be employedin one or more of the following clinical applications. The followingclinical applications are non-exhaustive and merely illustrativeapplications for one or more of the various surgical visualizationsystems disclosed herein.

A surgical visualization system, as disclosed herein, can be employed ina number of different types of procedures for different medicalspecialties, such as urology, gynecology, oncology, colorectal,thoracic, bariatric/gastric, and hepato-pancreato-biliary (HPB), forexample. In urological procedures, such as a prostatectomy, for example,the ureter may be detected in fat or connective tissue and/or nerves maybe detected in fat, for example. In gynecological oncology procedures,such as a hysterectomy, for example, and in colorectal procedures, suchas a low anterior resection (LAR) procedure, for example, the ureter maybe detected in fat and/or in connective tissue, for example. In thoracicprocedures, such as a lobectomy, for example, a vessel may be detectedin the lung or in connective tissue and/or a nerve may be detected inconnective tissue (e.g., an esophagostomy). In bariatric procedures, avessel may be detected in fat. In HPB procedures, such as a hepatectomyor pancreatectomy, for example, a vessel may be detected in fat(extrahepatic), in connective tissue (extrahepatic), and the bile ductmay be detected in parenchyma (liver or pancreas) tissue.

In one example, a clinician may want to remove an endometrial myoma.From a preoperative magnetic resonance imaging (MRI) scan, the clinicianmay know that the endometrial myoma is located on the surface of thebowel. Therefore, the clinician may want to know, intraoperatively, whattissue constitute a portion of the bowel and what tissue constitutes aportion of the rectum. In such instances, a surgical visualizationsystem, as disclosed herein, can indicate the different types of tissue(bowel versus rectum) and convey that information to a clinician via animaging system. Moreover, the imaging system can determine andcommunicate the proximity of a surgical device to the select tissue. Insuch instances, the surgical visualization system can provide increasedprocedural efficiency without critical complications.

In another example, a clinician (e.g. a gynecologist) may stay away fromcertain anatomic regions to avoid getting too close to criticalstructures and, thus, the clinician may not remove all of theendometriosis, for example. A surgical visualization system, asdisclosed herein, can enable the gynecologist to mitigate the risk ofgetting too close to the critical structure such that the gynecologistcan get close enough with the surgical device to remove all theendometriosis, which can improve the patient outcomes (democratizingsurgery). Such a system can enable the surgeon to “keep moving” duringthe surgical procedure instead of repeatedly stopping and restarting inorder to identify areas to avoid, especially during the application oftherapeutic energy such as ultrasonic or electrosurgical energy, forexample. In gynecological applications, uterine arteries and ureters areimportant critical structures and the system may be particularly usefulfor hysterectomy and endometriosis procedures given the presentationand/or thickness of tissue involved.

In another example, a clinician may risk dissection of a vessel at alocation that is too proximal and, thus, which can affect blood supplyto a lobe other than the target lobe. Moreover, anatomic differencesfrom patient to patient may lead to dissection of a vessel (e.g. abranch) that affects a different lobe based on the particular patient. Asurgical visualization system, as disclosed herein, can enable theidentification of the correct vessel at the desired location, whichenables the clinician to dissect with appropriate anatomic certainty.For example, the system can confirm that the correct vessel is in thecorrect place and then the clinician can safely divide the vessel.

In another example, a clinician may make multiple dissections beforedissecting at the best location due to uncertainty about the anatomy ofthe vessel. However, it is desirable to dissect in the best location inthe first instance because more dissection can increase the risk ofbleeding. A surgical visualization system, as disclosed herein, canminimize the number of dissections by indicating the correct vessel andthe best location for dissection. Ureters and cardinal ligaments, forexample, are dense and provide unique challenges during dissection. Insuch instances, it can be especially desirable to minimize the number ofdissections.

In another example, a clinician (e.g. a surgical oncologist) removingcancerous tissue may want to know the identification of criticalstructures, localization of the cancer, staging of the cancer, and/or anevaluation of tissue health. Such information is beyond what a cliniciansees with the “naked eye”. A surgical visualization system, as disclosedherein, can determine and/or convey such information to the clinicianintraoperatively to enhance intraoperative decision making and improvesurgical outcomes. In certain instances, the surgical visualizationsystem can be compatible with minimally invasive surgery (MIS), opensurgery, and/or robotic approaches using either an endoscope orexoscope, for example.

In another example, a clinician (e.g. a surgical oncologist) may want toturn off one or more alerts regarding the proximity of a surgical toolto one or more critical structure to avoid being overly conservativeduring a surgical procedure. In other instances, the clinician may wantto receive certain types of alerts, such as haptic feedback (e.g.vibrations/buzzing) to indicate proximity and/or or “no fly zones” tostay sufficiently far away from one or more critical structures. Asurgical visualization system, as disclosed herein, can provideflexibility based on the experience of the clinician and/or desiredaggressiveness of the procedure, for example. In such instances, thesystem provides a balance between “knowing too much” and “knowingenough” to anticipate and avoid critical structures. The surgicalvisualization system can assist in planning the next step(s) during asurgical procedure.

Various aspects of the subject matter described herein are set out inthe following numbered examples.

Example 1. A surgical control system communicably connectable to aback-end computer system, the surgical control system comprising animaging system and a control circuit coupled to the imaging system. Theimaging system comprises an emitter configured to emit electromagneticradiation (EMR) and an image sensor configured to receive the EMRreflected from a surgical site. At least a portion of the EMR is emittedas structured EMR. The control circuit is configured to generate animage of the surgical site via the reflected EMR received by the imagesensor, determine a surgical action being performed based on the image,receive a baseline surgical action associated with the surgical actionfrom the back-end computer system, and provide a user recommendationaccording to a comparison between the surgical action and the baselinesurgical action.

Example 2. The surgical control system of Example 1, wherein thesurgical control system is communicably coupled to a display screen andthe user recommendation comprises a graphical representation of thebaseline surgical action relative to the surgical action displayed onthe display screen.

Example 3. The surgical control system of Examples 1 or 2, wherein thecontrol circuit is configured to provide the user recommendationaccording to whether the comparison between the surgical action and thebaseline surgical action differs by at least a threshold.

Example 4. The surgical control system of any one of Examples 1-3,wherein the control circuit is further configured to receiveperioperative data and determine a surgical action being performed basedon the image and the received perioperative data.

Example 5. The surgical control system of Example 4, wherein theperioperative data comprises at least one of surgical generator data orsurgical instrument sensor data.

Example 6. The surgical control system of any one of Examples 1-5,wherein a surgical hub communicably connected to one or more surgicaldevices comprises the surgical control system.

Example 7. The surgical control system of any one of Examples 1-5,wherein the surgical control system is communicably connectable to asurgical hub and the control circuit is configured to determine thesurgical action being performed based on the image according to ananalysis algorithm and receive an update to the analysis algorithm fromthe surgical hub.

Example 8. A computer system communicably connectable to a plurality ofsurgical hubs, the plurality of surgical hubs each communicablyconnectable to an imaging system, the computer system comprising acontrol circuit configured to receive, from the plurality of surgicalhubs, a plurality of images of a plurality of surgical sites as capturedby each imaging system during a plurality of surgical procedures,determine a plurality of surgical outcomes, each of the plurality ofsurgical outcomes associated with one of the plurality of surgicalprocedures and based upon one of the plurality of images, determine abaseline surgical action according to the plurality of images and theplurality of surgical outcomes, and transmit the baseline surgicalaction to the plurality of surgical hubs.

Example 9. The computer system of Example 8, wherein the control circuitis configured to train a machine learning model to correlate a surgicalaction with a positive surgical outcome based on the plurality of imagesand the plurality of surgical outcomes to determine the baselinesurgical action for each surgical action.

Example 10. The computer system of Examples 8 or 9, wherein the controlcircuit is configured to receive, from the plurality of surgical hubs,perioperative data associated with the plurality of surgical proceduresand determine the plurality of surgical outcomes based on the pluralityof images and the perioperative data.

Example 11. The computer system of any one of Examples 8-10, wherein thecontrol circuit is configured to receive the plurality of surgicaloutcomes as input by a user.

Example 12. A method of controlling a surgical system communicablyconnectable to a back-end computer system, the control system comprisingan imaging system, the imaging system comprising an emitter configuredto emit electromagnetic radiation (EMR), wherein at least a portion ofthe EMR is emitted as structured EMR and an image sensor configured toreceive the EMR reflected from a surgical site, the method comprisinggenerating an image of the surgical site via the reflected EMR receivedby the image sensor, determining a surgical action being performed basedon the image, receiving a baseline surgical action associated with thesurgical action from the back-end computer system, and providing a userrecommendation according to a comparison between the surgical action andthe baseline surgical action.

Example 13. The method of Example 12, wherein the surgical systemcomprises a display screen and the user recommendation comprises agraphical representation of the baseline surgical action relative to thesurgical action displayed on the display screen.

Example 14. The method of Example 12 or 13, wherein the userrecommendation is provided according to whether the comparison betweenthe surgical action and the baseline surgical action differs by at leasta threshold.

Example 15. The method of any one of Examples 12-14, further comprisingreceiving perioperative data and determining a surgical action beingperformed based on the image and the received perioperative data.

Example 16. The method of Example 15, wherein the perioperative datacomprises at least one of surgical generator data or surgical instrumentsensor data.

Example 17. The method of any one of Examples 12-16, wherein thesurgical system comprises a surgical hub and the method furthercomprises determining the surgical action being performed based on theimage according to an analysis algorithm and receiving an update to theanalysis algorithm from the surgical hub.

While several forms have been illustrated and described, it is not theintention of Applicant to restrict or limit the scope of the appendedclaims to such detail. Numerous modifications, variations, changes,substitutions, combinations, and equivalents to those forms may beimplemented and will occur to those skilled in the art without departingfrom the scope of the present disclosure. Moreover, the structure ofeach element associated with the described forms can be alternativelydescribed as a means for providing the function performed by theelement. Also, where materials are disclosed for certain components,other materials may be used. It is therefore to be understood that theforegoing description and the appended claims are intended to cover allsuch modifications, combinations, and variations as falling within thescope of the disclosed forms. The appended claims are intended to coverall such modifications, variations, changes, substitutions,modifications, and equivalents.

The foregoing detailed description has set forth various forms of thedevices and/or processes via the use of block diagrams, flowcharts,and/or examples. Insofar as such block diagrams, flowcharts, and/orexamples contain one or more functions and/or operations, it will beunderstood by those within the art that each function and/or operationwithin such block diagrams, flowcharts, and/or examples can beimplemented, individually and/or collectively, by a wide range ofhardware, software, firmware, or virtually any combination thereof.Those skilled in the art will recognize that some aspects of the formsdisclosed herein, in whole or in part, can be equivalently implementedin integrated circuits, as one or more computer programs running on oneor more computers (e.g., as one or more programs running on one or morecomputer systems), as one or more programs running on one or moreprocessors (e.g., as one or more programs running on one or moremicroprocessors), as firmware, or as virtually any combination thereof,and that designing the circuitry and/or writing the code for thesoftware and or firmware would be well within the skill of one of skillin the art in light of this disclosure. In addition, those skilled inthe art will appreciate that the mechanisms of the subject matterdescribed herein are capable of being distributed as one or more programproducts in a variety of forms, and that an illustrative form of thesubject matter described herein applies regardless of the particulartype of signal bearing medium used to actually carry out thedistribution.

Instructions used to program logic to perform various disclosed aspectscan be stored within a memory in the system, such as dynamic randomaccess memory (DRAM), cache, flash memory, or other storage.Furthermore, the instructions can be distributed via a network or by wayof other computer readable media. Thus a machine-readable medium mayinclude any mechanism for storing or transmitting information in a formreadable by a machine (e.g., a computer), but is not limited to, floppydiskettes, optical disks, compact disc, read-only memory (CD-ROMs), andmagneto-optical disks, read-only memory (ROMs), random access memory(RAM), erasable programmable read-only memory (EPROM), electricallyerasable programmable read-only memory (EEPROM), magnetic or opticalcards, flash memory, or a tangible, machine-readable storage used in thetransmission of information over the Internet via electrical, optical,acoustical or other forms of propagated signals (e.g., carrier waves,infrared signals, digital signals, etc.). Accordingly, thenon-transitory computer-readable medium includes any type of tangiblemachine-readable medium suitable for storing or transmitting electronicinstructions or information in a form readable by a machine (e.g., acomputer).

As used in any aspect herein, the term “control circuit” may refer to,for example, hardwired circuitry, programmable circuitry (e.g., acomputer processor including one or more individual instructionprocessing cores, processing unit, processor, microcontroller,microcontroller unit, controller, digital signal processor (DSP),programmable logic device (PLD), programmable logic array (PLA), orfield programmable gate array (FPGA)), state machine circuitry, firmwarethat stores instructions executed by programmable circuitry, and anycombination thereof. The control circuit may, collectively orindividually, be embodied as circuitry that forms part of a largersystem, for example, an integrated circuit (IC), an application-specificintegrated circuit (ASIC), a system on-chip (SoC), desktop computers,laptop computers, tablet computers, servers, smart phones, etc.Accordingly, as used herein “control circuit” includes, but is notlimited to, electrical circuitry having at least one discrete electricalcircuit, electrical circuitry having at least one integrated circuit,electrical circuitry having at least one application specific integratedcircuit, electrical circuitry forming a general purpose computing deviceconfigured by a computer program (e.g., a general purpose computerconfigured by a computer program which at least partially carries outprocesses and/or devices described herein, or a microprocessorconfigured by a computer program which at least partially carries outprocesses and/or devices described herein), electrical circuitry forminga memory device (e.g., forms of random access memory), and/or electricalcircuitry forming a communications device (e.g., a modem, communicationsswitch, or optical-electrical equipment). Those having skill in the artwill recognize that the subject matter described herein may beimplemented in an analog or digital fashion or some combination thereof.

As used in any aspect herein, the term “logic” may refer to an app,software, firmware and/or circuitry configured to perform any of theaforementioned operations. Software may be embodied as a softwarepackage, code, instructions, instruction sets and/or data recorded onnon-transitory computer readable storage medium. Firmware may beembodied as code, instructions or instruction sets and/or data that arehard-coded (e.g., nonvolatile) in memory devices.

As used in any aspect herein, the terms “component,” “system,” “module”and the like can refer to a computer-related entity, either hardware, acombination of hardware and software, software, or software inexecution.

As used in any aspect herein, an “algorithm” refers to a self-consistentsequence of steps leading to a desired result, where a “step” refers toa manipulation of physical quantities and/or logic states which may,though need not necessarily, take the form of electrical or magneticsignals capable of being stored, transferred, combined, compared, andotherwise manipulated. It is common usage to refer to these signals asbits, values, elements, symbols, characters, terms, numbers, or thelike. These and similar terms may be associated with the appropriatephysical quantities and are merely convenient labels applied to thesequantities and/or states.

A network may include a packet switched network. The communicationdevices may be capable of communicating with each other using a selectedpacket switched network communications protocol. One examplecommunications protocol may include an Ethernet communications protocolwhich may be capable permitting communication using a TransmissionControl Protocol/Internet Protocol (TCP/IP). The Ethernet protocol maycomply or be compatible with the Ethernet standard published by theInstitute of Electrical and Electronics Engineers (IEEE) titled “IEEE802.3 Standard”, published in December, 2008 and/or later versions ofthis standard. Alternatively or additionally, the communication devicesmay be capable of communicating with each other using an X.25communications protocol. The X.25 communications protocol may comply orbe compatible with a standard promulgated by the InternationalTelecommunication Union-Telecommunication Standardization Sector(ITU-T). Alternatively or additionally, the communication devices may becapable of communicating with each other using a frame relaycommunications protocol. The frame relay communications protocol maycomply or be compatible with a standard promulgated by ConsultativeCommittee for International Telegraph and Telephone (CCITT) and/or theAmerican National Standards Institute (ANSI). Alternatively oradditionally, the transceivers may be capable of communicating with eachother using an Asynchronous Transfer Mode (ATM) communications protocol.The ATM communications protocol may comply or be compatible with an ATMstandard published by the ATM Forum titled “ATM-MPLS NetworkInterworking 2.0” published August 2001, and/or later versions of thisstandard. Of course, different and/or after-developedconnection-oriented network communication protocols are equallycontemplated herein.

Unless specifically stated otherwise as apparent from the foregoingdisclosure, it is appreciated that, throughout the foregoing disclosure,discussions using terms such as “processing,” “computing,”“calculating,” “determining,” “displaying,” or the like, refer to theaction and processes of a computer system, or similar electroniccomputing device, that manipulates and transforms data represented asphysical (electronic) quantities within the computer system's registersand memories into other data similarly represented as physicalquantities within the computer system memories or registers or othersuch information storage, transmission or display devices.

One or more components may be referred to herein as “configured to,”“configurable to,” “operable/operative to,” “adapted/adaptable,” “ableto,” “conformable/conformed to,” etc. Those skilled in the art willrecognize that “configured to” can generally encompass active-statecomponents and/or inactive-state components and/or standby-statecomponents, unless context requires otherwise.

The terms “proximal” and “distal” are used herein with reference to aclinician manipulating the handle portion of the surgical instrument.The term “proximal” refers to the portion closest to the clinician andthe term “distal” refers to the portion located away from the clinician.It will be further appreciated that, for convenience and clarity,spatial terms such as “vertical”, “horizontal”, “up”, and “down” may beused herein with respect to the drawings. However, surgical instrumentsare used in many orientations and positions, and these terms are notintended to be limiting and/or absolute.

Those skilled in the art will recognize that, in general, terms usedherein, and especially in the appended claims (e.g., bodies of theappended claims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to claims containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations.

In addition, even if a specific number of an introduced claim recitationis explicitly recited, those skilled in the art will recognize that suchrecitation should typically be interpreted to mean at least the recitednumber (e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that typically a disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms unless context dictates otherwise. For example, the phrase “Aor B” will be typically understood to include the possibilities of “A”or “B” or “A and B.”

With respect to the appended claims, those skilled in the art willappreciate that recited operations therein may generally be performed inany order. Also, although various operational flow diagrams arepresented in a sequence(s), it should be understood that the variousoperations may be performed in other orders than those which areillustrated, or may be performed concurrently. Examples of suchalternate orderings may include overlapping, interleaved, interrupted,reordered, incremental, preparatory, supplemental, simultaneous,reverse, or other variant orderings, unless context dictates otherwise.Furthermore, terms like “responsive to,” “related to,” or otherpast-tense adjectives are generally not intended to exclude suchvariants, unless context dictates otherwise.

It is worthy to note that any reference to “one aspect,” “an aspect,”“an exemplification,” “one exemplification,” and the like means that aparticular feature, structure, or characteristic described in connectionwith the aspect is included in at least one aspect. Thus, appearances ofthe phrases “in one aspect,” “in an aspect,” “in an exemplification,”and “in one exemplification” in various places throughout thespecification are not necessarily all referring to the same aspect.Furthermore, the particular features, structures or characteristics maybe combined in any suitable manner in one or more aspects.

Any patent application, patent, non-patent publication, or otherdisclosure material referred to in this specification and/or listed inany Application Data Sheet is incorporated by reference herein, to theextent that the incorporated materials is not inconsistent herewith. Assuch, and to the extent necessary, the disclosure as explicitly setforth herein supersedes any conflicting material incorporated herein byreference. Any material, or portion thereof, that is said to beincorporated by reference herein, but which conflicts with existingdefinitions, statements, or other disclosure material set forth hereinwill only be incorporated to the extent that no conflict arises betweenthat incorporated material and the existing disclosure material.

In summary, numerous benefits have been described which result fromemploying the concepts described herein. The foregoing description ofthe one or more forms has been presented for purposes of illustrationand description. It is not intended to be exhaustive or limiting to theprecise form disclosed. Modifications or variations are possible inlight of the above teachings. The one or more forms were chosen anddescribed in order to illustrate principles and practical application tothereby enable one of ordinary skill in the art to utilize the variousforms and with various modifications as are suited to the particular usecontemplated. It is intended that the claims submitted herewith definethe overall scope.

1. A surgical virtualization analysis system communicably coupled to aback-end computer system, the surgical virtualization analysis systemcomprising: an imaging system comprising: an emitter configured to emitelectromagnetic radiation (EMR), wherein at least a portion of the EMRis emitted as structured EMR; and an image sensor configured to receivethe EMR reflected from a surgical site; and a control circuit coupled tothe imaging system, the control circuit configured to: identify anintraoperative surgical procedure that is being performed at thesurgical site based on imaging data received from the imaging system;retrieve a data set comprising a set of baseline surgical proceduralsteps associated with the intraoperative surgical procedure, wherein theset of baseline surgical procedural steps are determined based on aplurality of previous instances of the intraoperative surgicalprocedure, and wherein the set of baseline surgical procedural steps arestored at the back-end computer system; monitor the performance of theintraoperative surgical procedure in real-time relative to the set ofbaseline surgical procedural steps; identify a deviation from the set ofbaseline surgical procedural steps corresponding to a surgical action ofthe surgical procedure, wherein the identification is based on imagingdata received from the imaging system; determine a recommended action tobe performed in response to the deviation in the surgical action of thesurgical procedure; and output the recommendation as a virtualizedgraphical overlay on a live video feed of the surgical procedure,wherein the recommendation is displayed on an output display.
 2. Thesurgical virtualization analysis system of claim 1, wherein the controlcircuit is further configured to: compare the surgical action to anassociated step in the set of baseline surgical procedural steps;determine that the surgical action deviates by an amount from theassociated step in the set of baseline surgical procedural steps; anddetermine a recommended surgical action to be performed in response tothe amount of deviation.
 3. The surgical virtualization analysis systemof claim 2, wherein the associated step in the set of baseline surgicalprocedural steps is identified by image recognition data, wherein theimage recognition data comprises a comparison of imaging data receivedfrom the imaging system to the set of baseline surgical procedural step,and wherein the imaging data comprises at least a specific organ ortissue type, or a surgical instrument used in the procedure.
 4. Thesurgical virtualization analysis system of claim 2, wherein the controlcircuit is further configure to: receive imaging data from the imagingsystem for a target anatomy for the surgical procedure; generate avirtualized map of the target anatomy; and determine a distance betweenthe target anatomy and a surgical instrument.
 5. The surgicalvirtualization analysis system of claim 1, wherein the recommendedgraphical overlay is a virtualized image of a surgical instrument in arecommended position according to the set of baseline surgicalprocedural steps.
 6. A method for virtualizing real-time surgicalrecommendations, the method comprising: aggregating, by a back-endcomputing system, a plurality of data points associated with a surgicalprocedure, wherein the plurality of data points are associated with aplurality of pervious instances of the surgical procedure; identifying,by a control circuit, an intraoperative surgical procedure beingperformed at the surgical site based on imaging data received from animaging system; retrieving, by the control circuit, a data setcomprising a set of baseline surgical procedural steps associated withthe intraoperative surgical procedure, wherein the set of baselinesurgical procedural steps are determined based on a plurality ofprevious instances of the intraoperative surgical procedure, and whereinthe set of baseline surgical procedural steps are stored at the back-endcomputer system; monitoring, by the control circuit, the performance ofthe intraoperative surgical procedure in real-time relative to the setof baseline surgical procedural steps; identifying, by the controlcircuit, a deviation from the set of baseline surgical procedural stepscorresponding to a surgical action of the surgical procedure, whereinthe identification is based on imaging data received from the imagingsystem; determining, by the control circuit, a recommended action to beperformed in response to the deviation in the surgical action of thesurgical procedure; and displaying, on an output device, the recommendedaction as a virtualized graphical overlay on a live video feed of thesurgical procedure.
 7. The method for virtualizing real-time surgicalrecommendations of claim 6, further comprising: comparing, by thecontrol circuit, the surgical action to an associated step in the set ofbaseline surgical procedural steps; determining, by the control circuit,that the surgical action deviates by an amount from the associated stepin the set of baseline surgical procedural steps; and determining, bythe control circuit, a recommended surgical action to be performed inresponse to the amount of deviation.
 8. The method for virtualizingreal-time surgical recommendations of claim 7, wherein the associatedstep in the set of baseline surgical procedural steps is identified byimage recognition data, wherein the image recognition data comprises acomparison of the imaging data received from the imaging system to theset of baseline surgical procedural step, and wherein the imaging datacomprises at least a specific organ or tissue type, or a surgicalinstrument used in the procedure.
 9. The method for virtualizingreal-time surgical recommendations of claim 97 further comprising:receiving, by the control circuit, imaging data from the imaging systemfor a target anatomy for the surgical procedure; generating, by thecontrol circuit, a virtualized map of the target anatomy; anddetermining, by the control circuit, a distance between the targetanatomy and a surgical instrument.
 10. The method for virtualizingreal-time surgical recommendations of claim 6, wherein the recommendedgraphical overlay is a virtualized image of a surgical instrument in arecommended position according to the set of baseline surgicalprocedural steps.
 11. A non-transitory computer readable mediumcomprising instructions stored thereon that, when executed by one ormore than one processor, cause the one or more than one processor to:aggregate, by a back-end computing system, a plurality of data pointsassociated with a surgical procedure, wherein the plurality of datapoints are associated with a plurality of previous instances of thesurgical procedure; identify, by a control circuit, an intraoperativesurgical procedure being performed at the surgical site based on imagingdata received from an imaging system;
 12. The non-transitory computerreadable medium of claim 11, further comprising instructions storedthereon that, when executed by the one or more than one processor, causethe one or more than one processor to: compare, by the control circuit,the surgical action to an associated step in the set of baselinesurgical procedural steps; determine, by the control circuit, that thesurgical action deviates by an amount from the associated step in theset of baseline surgical procedural steps; determine, by the controlcircuit, a recommended surgical action to be performed in response tothe amount of deviation.
 13. The non-transitory computer readable mediumof claim 12, wherein the associated step in the set of baseline surgicalprocedural steps is identified by image recognition data, wherein theimage recognition data comprises a comparison of imaging data receivedfrom the imaging system to the set of baseline surgical procedural step,and wherein the imaging data comprises at least a specific organ ortissue type, or surgical instrument used in the procedure.
 14. Thenon-transitory computer readable medium of claim 12, further comprisinginstructions stored thereon that, when executed by the one or more thanone processor, cause the one or more than one processor to: receive, bythe control circuit, imaging data from the imaging system for a targetanatomy for the surgical procedure; generate, by the control circuit, avirtualized map of the target anatomy; and determine, by the controlcircuit, a distance between the target anatomy and a surgicalinstrument.
 15. The non-transitory computer readable medium of claim 11,wherein the recommended graphical overlay is a virtualized image of asurgical instrument in a recommended position according to the set ofbaseline surgical procedural steps.